FDA.reportPublic FDA data

Nifedipine

Product NDC
50742-620
11-digit product format
507420620
Labeler code
50742
Product ID
50742-620_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
30 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
NIFEDIPINE30 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
50742-620-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-620NIFEDIPINE 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 TabletPSN18c37b07-aaa3-4285-b2d7-7e81099dea9e3
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
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD18c37b07-aaa3-4285-b2d7-7e81099dea9e3
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 TabletSY18c37b07-aaa3-4285-b2d7-7e81099dea9e3
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
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN1b98b011-793c-ed92-e063-6294a90ac2bc1
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNff090952-9f69-43c3-8e29-6e159c72b1c51
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD1b98b011-793c-ed92-e063-6294a90ac2bc1
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDff090952-9f69-43c3-8e29-6e159c72b1c51
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY1b98b011-793c-ed92-e063-6294a90ac2bc1
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYff090952-9f69-43c3-8e29-6e159c72b1c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-620-0150742062001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-620-01) 2017-02-150000-00-00NoNoCurrent