FDA.reportPublic FDA data

NDC 67046-515-03 - nifedipine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67046-515
Requested NDC
67046-515-03
Package NDCs from labels
67046-515-30, 67046-515-03
Manufacturer
Contract Pharmacy Services-PA
Effective date
2010-04-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
nifedipine - Contract Pharmacy Services-PAContract Pharmacy Services-PA2010-04-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-515-302019-10-21C16284748780-1956f9ecf-c6d2-621f-e053-dbdaa90a74adNIFEDIPINE EXTENDED-RELEASE TABLETS 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-515-30nifedipine30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-515NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100413_43062486-bbac-47e4-bae1-16924338c8d8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nifedipineACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1
nifedipineACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 19 · 361 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.bc9385d0-5c67-4bde-94da-e621347e2cba2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.4c903249-69e9-4168-a9d1-22e6c2c1eb222026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6f25cbb3-0358-4778-b8f0-f76479a2dcc52026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.7fd988be-ab3d-406d-a55d-1e5a8a2101cc2026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6108759a-783e-42ca-b078-6a3cd84ce9012026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.13e03769-9a4f-497f-9afa-95bf525090b32026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
unii: 9J765S329G
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNorthStar RxLLC58f4dc90-3648-49dc-a7e1-baf918a773b52026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 966225
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.597ea445-d926-adc6-e063-6394a90a64462026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
unii: 9J765S329G
NifedipineNIFEDIPINEPreferred Pharmaceuticals Inc.cda16a27-f029-40a6-a0e8-2bed0de711692026-08-04Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L
NifedipineNIFEDIPINEPreferred Pharmaceuticals, Inc.4ee466dc-5a4e-4c77-8e94-8b510cafd61b2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 1812011
unii: I9ZF7L6G2L
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f4c679-86cb-b97f-e063-6294a90ad5ef2026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
unii: 9J765S329G
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f67831-4680-edbf-e063-6294a90a1d362026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
unii: 9J765S329G
NifedipineNIFEDIPINEMajor Pharmaceuticalsacb493a3-b8f2-41a9-8ab2-550d97c4592a2026-06-30Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1add684f-d082-72cc-e063-6394a90a12142026-06-29Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack489ffba8-983e-478f-8f62-fe08bf3d0e0b2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
NifedipineNIFEDIPINESt. Mary's Medical Park Pharmacy1ab8945b-bea5-9827-e063-6294a90af3342026-06-17Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L
NifedipineNIFEDIPINEGolden State Medical Supply, Inc.d9a501be-8523-3924-e053-2995a90a85692026-06-16Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC544d67eb-8487-cb5d-e063-6394a90a31102026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA209713
unii: 9J765S329G
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack3b282e57-1009-4d2c-8ca2-9cca9f7919372026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9J765S329G
NifedipineNIFEDIPINECardinal Health 107, LLCc98ecf77-ae9a-438b-9bad-ffbed25d95bc2026-06-11Warnings, Adverse reactionsExact identifier
unii: I9ZF7L6G2L

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.