FDA.reportPublic FDA data

Nifedipine

Product NDC
43386-440
11-digit product format
433860440
Labeler code
43386
Product ID
43386-440_75c72876-28a3-5fc5-e053-2a91aa0acc70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals Inc
Application
ANDA072781
Marketing category
ANDA
Marketing start
2009-08-11
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43386-440-242020-01-31C16284748780-19d75b9d0-37ae-f424-e053-dadaa90a57ceNifedipine Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-440-24Nifedipine100 in 1 BOTTLECAPSULE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-440-24EA - Each43386-440847decbe-4c21-4b4a-a529-39df8fc2110112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE CAPSULE [CARILION MATERIALS MANAGEMENT]2
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ONIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNIFEDIPINE (NIFEDIPINE) CAPSULE [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-440NIFEDIPINE CAPSULE [LUPIN PHARMACEUTICALS INC]5Legacy NDC, 1 package rows20180928_0cc236dc-95fa-49cc-aeb8-6590de157585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN0cc236dc-95fa-49cc-aeb8-6590de1575855
198032nifedipine 10 MG Oral CapsuleSCD0cc236dc-95fa-49cc-aeb8-6590de1575855
198032NIFEdipine 10 MG Oral CapsulePSN4f43889f-3e6a-6a5c-e054-00144ff8d46c3
198032NIFEdipine 10 MG Oral CapsulePSN9b0263a7-c492-40ea-e053-2a95a90a561e3
198032nifedipine 10 MG Oral CapsuleSCD4f43889f-3e6a-6a5c-e054-00144ff8d46c3
198032nifedipine 10 MG Oral CapsuleSCD9b0263a7-c492-40ea-e053-2a95a90a561e3
198032NIFEdipine 10 MG Oral CapsulePSNce3366e2-ede3-4321-bd1c-8aacc869fe462
198032nifedipine 10 MG Oral CapsuleSCDce3366e2-ede3-4321-bd1c-8aacc869fe462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43386-440-2443386044024100 in 1 BOTTLEHistorical