National Drug Codes piav qhia

National Drug Code (NDC) yog dab tsi?

NDC, lossis National Drug Code, yog ib qho tshwj xeeb 10-tus lej lossis 11-tus lej, 3-ntu tus lej, thiab cov khoom lag luam thoob ntiaj teb rau tib neeg cov tshuaj hauv Tebchaws Meskas.

3 ntu ntawm NDC txheeb xyuas: daim ntawv lo, cov khoom lag luam, thiab cov khoom lag luam loj.

  • Thawj pawg ntawm cov lej hauv NDC txheeb xyuas cov ntawv sau npe, xws li kws tsim tshuaj , repackager, lossis distributer.
  • Cov lej thib ob yog cov lej ntawm cov khoom lag luam, uas qhia txog lub zog tshwj xeeb, daim ntawv ntau npaum li cas (piv txwv li, tshuaj ntsiav, ntsiav tshuaj, kua) thiab kev tsim cov tshuaj rau ib daim ntawv lo tshwj xeeb.
  • Thaum kawg, qhov thib peb txheej yog pob code, uas txheeb xyuas pob qhov ntau thiab tsawg thiab hom.

Daim ntawv lo code yog muab los ntawm US Food and Drug Administration (FDA), thaum cov khoom thiab pob code raug muab los ntawm lub labeler. Rau kev them nqi lossis lwm lub hom phiaj, xws li nrog Lub Chaw Pabcuam Medicare & Medicaid (CMS), NDC kuj tseem tuaj yeem npaj ua 11 tus lej nrog tus lej lej, yog tias xav tau.



NDC Phau Ntawv Qhia yog txwv rau txhua tus over-tus-counter (OTC) cov tshuaj, cov tshuaj noj , thiab insulin Cov pob khoom hauv Teb Chaws Asmeskas FDA tshaj tawm cov npe 10-tus lej NDC thiab cov ntaub ntawv xa tuaj ua ib feem ntawm cov ntaub ntawv teev npe hauv NDC Phau Ntawv Qhia uas tau hloov kho tsis tu ncua.

Raws li lub Rau Hli 1, 2011, tsuas yog cov tshuaj uas cov npe hauv hluav taws xob (Structured Product Labeling lossis SPL) tau xa mus rau FDA tau suav nrog hauv NDC Phau Ntawv Qhia. Cov tshuaj tsiaj, cov khoom siv ntshav, lossis cov tshuaj tib neeg, thiab lwm yam, uas tsis yog nyob rau hauv daim ntawv muag khoom zaum kawg tsis suav nrog hauv NDC phau ntawv.

colace siv rau dab tsi

NDC formatted li cas?

10 tus lej NDC yuav nyob rau hauv ib qho ntawm cov kev teeb tsa hauv qab no: 4-4-2, 5-3-2, lossis 5-4-1, txhais tau tias muaj 4 lossis 5 tus lej rau tus lej cim npe, 4 lossis 3 tus lej rau cov khoom code thiab 2 lossis 1 tus lej (s) rau pob code.

Example NDC

Piv txwv li, NDC rau 100- suav lub raj mis ntawm Prozac 20 mg yog 0777-3105-02.

Thawj ntu txheeb xyuas cov ntawv sau (cov ntawv cim npe '0777' yog rau Dista Products Co., tus sau npe ntawm Prozac).

cor 136 paj yeeb txoj kev tus nqi

Ntu thib ob, cov khoom lag luam code, txheeb xyuas lub zog, daim ntawv ntau npaum li cas (piv txwv li, tshuaj ntsiav, ntsiav tshuaj, kua) thiab kev tsim cov tshuaj rau ib daim ntawv lo tshwj xeeb ('3105' txheeb xyuas tias daim ntawv ntau npaum li cas yog tshuaj ntsiav).

Qhov thib peb ntu yog pob code, thiab nws txheeb xyuas pob qhov ntau thiab tsawg thiab hom. Lub pob code '02' rau lub raj mis ntawm Prozac qhia tias 100 tsiav tshuaj nyob hauv lub raj mis.

Kuv tuaj yeem nrhiav NDC tus lej rau tshuaj nyob qhov twg?

Vim li cas qee cov khoom siv tshuaj tsis nyob hauv NDC Phau Ntawv Qhia?

Raws li FDA, cov laj thawj yog vim li cas cov khoom siv tshuaj yuav tsis tshwm sim hauv NDC Phau Ntawv Qhia, suav nrog:

zyrtec rau 1 xyoos
  • Cov khoom lag luam yuav tsis yog tshuaj noj, OTC, lossis cov khoom lag luam insulin.
  • lub tuam txhab tau ceeb toom rau FDA tias cov khoom no tsis muaj kev lag luam thiab ua lag luam lawm.
  • Cov chaw tsim khoom tsis tau muab cov npe ua tiav ntawm cov khoom siv tshuaj.

FDA xav kom cov ntawv sau npe tshuaj thiab cov ntaub ntawv teev npe tshuaj raug xa hauv tshuab hluav taws xob tshwj tsis yog tias muaj kev zam.

Vim li cas qee tus lej NDC muaj 11 tus lej?

Rau qee lub hom phiaj, suav nrog kev them nqi tsim nyog ntawm cov khoom siv tshuaj, yuav tsum muaj 11 tus lej NDC. Lub Chaw Pabcuam Medicare & Medicaid (CMS) thiab lwm lub koomhaum tseemfwv xav kom NDC yog ib feem ntawm lawv daim ntawv thov kev them nqi. Qee lub koomhaum tseemfwv, suav nrog HIPAA, tuaj yeem xav tau NDC hauv 11-tus lej hom nrog tus lej lej. Ntau ntxiv, cov neeg them nyiaj ntiag tug xav tau 11 tus lej code, tab sis cov cai tuaj yeem sib txawv heev.

  • Tus CMS NDC tus cim tau tsim ua 11 tus lej uas tsis muaj qhov chaw, hyphens lossis lwm yam cim.
  • Yog tias NDC pob code tsawg dua 11 tus lej (piv txwv li, tus qauv 4-4-2) cov lej yuav tsum tau padded nrog rau xoom.
  • Tus thawj xoom yog ntxiv rau ntu xav tau los tsim 5-4-2 teeb tsa.

NDC cov lej kuj tau tshwm sim nrog lub hnub qub hauv cov khoom lag luam lossis cov lej pob. Lub hnub qub ua raws li qhov chaw thiab qhia txog kev teeb tsa ntawm NDC.

Raws li FDA, vim muaj kev tsis sib haum xeeb nrog HIPAA tus qauv ntawm 11 tus lej NDC, ntau cov kev pabcuam yuav pad cov khoom code lossis pob code ntu ntawm NDC nrog rau xoom ua ntej siv lub hnub qub. Txawm li cas los xij, raws li FDA, asterisks tsis siv lossis suav nrog hauv cov khoom siv cov ntaub ntawv cov ntsiab lus los qhia qee qhov kev teeb tsa ntawm NDC.

Txij li tus xoom tuaj yeem yog tus lej siv tau hauv NDC, qhov no tuaj yeem ua rau tsis meej pem thaum sim rov qab 11 tus lej NDC rov qab rau nws 10 tus lej FDA tus qauv. Piv txwv li, raws li FDA tau sau tseg, 12345-0678-09 (11 tus lej) tuaj yeem yog 12345-678-09 lossis 12345-0678-9 nyob ntawm lub tuam txhab kev teeb tsa.

Koj yuav hloov 10 tus lej NDC li cas rau 11 tus lej NDC?

Ntau ntxiv, cov neeg them nyiaj xav tau 11 tus lej NDC code rau kev them nqi. Yog li, kev them nqi tsim nyog yuav xav tau qhov tshwj xeeb-tso xoom los tsim 5-4-2 hom nyob ntawm cov khoom siv tshuaj 10-tus lej NDC. Saib Table 1 rau cov piv txwv hloov dua siab tshiab.

lub sij hawm ntev los zoo wellbutrin

Nco ntsoov tias hyphens rau 11 tus lej NDC (hauv kab ntawv kawg hauv qab no) yog rau illustration purposes xwb , thiab yuav tsum tsis txhob siv thaum xa cov ntaub ntawv rau kev thov.

Table 1: 10-Digit to 11-Digit NDC Hloov

10-Digit Format ntawm pob 10-Digit Format ntawm pob Hloov 11-digit format Qhov tseeb 10 tus lej piv txwv 11-tus lej hloov pauv piv txwv
Table 1: Hloov los ntawm Maryland Dept. of Health (www.maryland.gov)
4-4-2 9999-9999-99 5-4-2 0777-3105-02 (Prozac) 00777-3105-02
5-3-2 99999-999-99 5-4-2 43063-609-30 (alprazolam) 43063-0609-30
5-4-1 99999-9999-9 5-4-2 11822-0544-1 (acetaminophen) 11822-0544-01 ib

Cov lej NDC siv li cas rau kev them nqi?

Thaum xa daim ntawv thov nyiaj rov qab, nws yog qhov zoo tshaj plaws los kuaj xyuas nrog cov neeg them nyiaj los txiav txim qhov tshwj xeeb rau NDA coding thiab them nyiaj rov qab, raws li cov cai sib txawv. Raws li American Academy of Pediatrics (AAP), ntau tus neeg them nyiaj zoo li Blue Cross thiab Blue Shield, Tricare, thiab lub xeev Medicaid cov phiaj xwm muaj kev taw qhia txog seb lawv xav kom NDC cov lej siv li cas. Tsis tas li ntawd, qee qhov kev npaj Medicaid tsis suav nrog kev siv NDC cov lej rau tshuaj tiv thaiv.

ceeb ntshai nres vs ntxhov siab vim

Puas yuav 10 tus lej NDC cov lej khiav tawm?

Yog lawm, FDA tau hais tias 5-tus lej hom muab 90,000 muaj peev xwm ua ke, thiab cia siab tias yuav khiav tawm ntawm cov lej cim los ntawm kwv yees li 2033.

Hauv xyoo 2018, FDA tau ua lub rooj sib hais rau pej xeem mloog cov neeg koom nrog kev lag luam kev noj qab haus huv los txiav txim siab cov kauj ruam tom ntej uas tsim nyog rau NDC txoj cai hloov. Cov FDA luam tawm txoj cai tau hais tseg: Cov Hom Phiaj Yav Tom Ntej ntawm National Drug Code; Lub Rooj Sib Hais Pej Xeem; Thov kom muaj lus pom nyob rau hauv Tsoom Fwv Teb Chaws Register (Docket No. FDA-2018-N-2610). Cov lus tshaj tawm rau pej xeem rau txoj cai tau lees paub txog thaum Lub Ib Hlis 5, 2019.

Raws li tau hais nyob rau hauv txoj cai, FDA yuav pib muab 6-tus lej cim npe ntawm qee lub sijhawm yav tom ntej vim kev qaug zog ntawm 5-tus lej cim npe. Tsiv mus txog 6-tus lej cim npe yuav nthuav NDCs mus rau 11 tus lej thiab tso cai rau ob qho kev teeb tsa NDC ntxiv: 6-3-2 thiab 6-4-1, rau tag nrho tsib qhov kev teeb tsa NDC (suav nrog peb 10 tus lej NDC configurations).

Qhov chaw

  1. Coding Corner: Yuav ua li cas siv National Drug Codes thaum them nqi tshuaj, tshuaj tiv thaiv. American Academy of Pediatrics (AAP). AAP Xov Xwm. Tau txais los ntawm Lub Ob Hlis 1, 2020 thaum https://www.aappublications.org/news/2016/04/21/Coding042116
  2. National Drug Code (NDC) Directory. US Food and Drug Administration (FDA). Tau txais los ntawm Lub Ob Hlis 1, 2020 thaum https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm
  3. National Drug Code Database Background Information. US Food and Drug Administration (FDA). Tau txais los ntawm Lub Ob Hlis 1, 2020 thaum https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information
  4. NDC Product File Definitions. US Food and Drug Administration (FDA). Tau txais los ntawm Lub Ob Hlis 1, 2020 thaum https://www.fda.gov/Drugs/InformationOnDrugs/ucm254527.htm
  5. Millonig M. Puas yog koj npaj rau kev lag luam loj hloov mus rau National Drug Code (NDC) Number? Wolters Kluwer. Tau txais los ntawm Lub Ob Hlis 1, 2020 thaum https://www.wolterskluwercdi.com/blog/major-industry-change-ndc/

Cov ntaub ntawv ntxiv

Nco ntsoov sab laj nrog koj tus kws kho mob kom paub meej tias cov ntaub ntawv uas tshwm sim hauv nplooj ntawv no siv tau rau koj tus kheej.