FDA.reportPublic FDA data

Nifedipine

Product NDC
62332-732
11-digit product format
623320732
Labeler code
62332
Product ID
62332-732_69114afa-390f-4134-9055-d0b539d45c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216896
Marketing category
ANDA
Marketing start
2022-11-23
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
Rxcui1812011, 1812013, 1812015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-732-31Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
62332-732-63Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3004
62332-732-91Nifedipine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-732NIFEDIPINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20221124_63f062f6-5669-434c-8ded-9801d8486dbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN63f062f6-5669-434c-8ded-9801d8486dbf4
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN63f062f6-5669-434c-8ded-9801d8486dbf4
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN63f062f6-5669-434c-8ded-9801d8486dbf4
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD63f062f6-5669-434c-8ded-9801d8486dbf4
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD63f062f6-5669-434c-8ded-9801d8486dbf4
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD63f062f6-5669-434c-8ded-9801d8486dbf4
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY63f062f6-5669-434c-8ded-9801d8486dbf4
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY63f062f6-5669-434c-8ded-9801d8486dbf4
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY63f062f6-5669-434c-8ded-9801d8486dbf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-732-3162332073231100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-732-31) 2022-11-230000-00-00NoNoCurrent
62332-732-6362332073263300 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-732-63) 2022-11-230000-00-00NoNoCurrent
62332-732-91623320732911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-732-91) 2022-11-230000-00-00NoNoCurrent