FDA.reportPublic FDA data

Nifedipine

Product NDC
59651-295
11-digit product format
596510295
Labeler code
59651
Product ID
59651-295_4d72a04e-43a6-4fa4-bd1c-1360c4539d71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213361
Marketing category
ANDA
Marketing start
2021-07-19
Substance
NIFEDIPINE
Active strength
30 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198034, 198035, 198036

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-295-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-295-01EA - Each59651-29572daf1c7-52c7-4e70-9b7b-103bb1181c4112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-295NIFEDIPINE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 1 package rows20250101_eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN1bd05e73-5104-4ef7-a705-22e2db140354100
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD1bd05e73-5104-4ef7-a705-22e2db140354100
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY1bd05e73-5104-4ef7-a705-22e2db140354100
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN3b0ae3ed-77ee-d0df-e063-6294a90a7d173
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD3b0ae3ed-77ee-d0df-e063-6294a90a7d173
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY3b0ae3ed-77ee-d0df-e063-6294a90a7d173
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSNeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCDeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSYeb70b7ff-f9f0-41d0-901a-f4c04ae9ed462
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN27d6c9c5-5a45-9cfc-e063-6394a90a72021
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD27d6c9c5-5a45-9cfc-e063-6394a90a72021
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY27d6c9c5-5a45-9cfc-e063-6394a90a72021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-295-0159651029501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-295-01) 2021-07-190000-00-00NoNoCurrent