FDA.reportPublic FDA data

Nifedipine

Product NDC
50742-621
11-digit product format
507420621
Labeler code
50742
Product ID
50742-621_182d5c87-db57-4042-a1e8-d2c78b07789b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA202987
Marketing category
ANDA
Marketing start
2017-02-15
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198034, 198035, 198036

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
50742-621-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-621-01EA - Each50742-621682650bd-0cae-4195-8a3a-59dbe5ad87f412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-621NIFEDIPINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 1 package rows20221217_4d02eba2-e964-4fa7-aaae-25949b5f0316.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN4d02eba2-e964-4fa7-aaae-25949b5f03168
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN4d02eba2-e964-4fa7-aaae-25949b5f03168
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN4d02eba2-e964-4fa7-aaae-25949b5f03168
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD4d02eba2-e964-4fa7-aaae-25949b5f03168
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD4d02eba2-e964-4fa7-aaae-25949b5f03168
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD4d02eba2-e964-4fa7-aaae-25949b5f03168
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY4d02eba2-e964-4fa7-aaae-25949b5f03168
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY4d02eba2-e964-4fa7-aaae-25949b5f03168
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY4d02eba2-e964-4fa7-aaae-25949b5f03168
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNd9a501be-8523-3924-e053-2995a90a85693
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNd9a501be-8523-3924-e053-2995a90a85693
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSNd9a501be-8523-3924-e053-2995a90a85693
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDd9a501be-8523-3924-e053-2995a90a85693
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDd9a501be-8523-3924-e053-2995a90a85693
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCDd9a501be-8523-3924-e053-2995a90a85693
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYd9a501be-8523-3924-e053-2995a90a85693
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYd9a501be-8523-3924-e053-2995a90a85693
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSYd9a501be-8523-3924-e053-2995a90a85693
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNda80fa84-9336-082c-e053-2a95a90a89872
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDda80fa84-9336-082c-e053-2a95a90a89872
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYda80fa84-9336-082c-e053-2a95a90a89872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-621-0150742062101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-621-01) 2017-02-150000-00-00NoNoCurrent