FDA.reportPublic FDA data

NDC 54868-4532-3 - 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
54868-4532
Requested NDC
54868-4532-3
Package NDCs from labels
54868-4532-0, 54868-4532-1, 54868-4532-3
Manufacturer
Physicians Total Care, Inc.
Effective date
2014-01-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nifedipine Extended-Release Tablets, USPPhysicians Total Care, Inc.2014-01-16HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54868-4532-02019-09-24C16284748780-19350213a-4754-c013-e053-90daa90a1393Nifedipine Extended-Release Tablets, USP
54868-4532-12019-09-24C16284748780-19350213a-4754-c013-e053-90daa90a1393Nifedipine Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-4532-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE304
54868-4532-1Nifedipine10 in 1 BOTTLETABLET, EXTENDED RELEASE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-4532NIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]42 package rows20140116_1e80b790-a57e-46ee-a257-4f59ca6502ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-4532-0EA - Each54868-45324df56e50-b5c2-4b71-b73e-57e37cf406c412012-07-24
54868-4532-1EA - Each54868-4532fcf7d831-0fe4-4680-ba59-07296dee403312012-07-24
54868-4532-2EA - Each54868-45320fe14e4b-7e6e-44d4-9819-71761cff3a6a12012-07-24
54868-4532-3EA - Each54868-4532c93c3be8-2513-417e-9484-d019fa74820512012-07-24
54868-4532-4EA - Each54868-4532a7a3cf9c-6217-4b12-9f6a-6481baa5483b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IENIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]4

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 55 of 134 · 2,661 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
unii: 15FIX9V2JP
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
unii: 15FIX9V2JP
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.eb744367-f318-e1e2-e053-2a95a90a2cc42025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242faaed-e85a-a1d7-e063-6294a90aea922025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247d6c0e-8f88-faf0-e063-6394a90a10da2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e8241828-17b2-96c5-e053-2a95a90a12e52025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.1176181b-1331-ba68-e063-6394a90a961a2025-12-09WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247b56ad-4b61-8b6f-e063-6394a90af3b62025-12-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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