Nifedipine

Product NDC
63629-9109
11-digit product format
636299109
Labeler code
63629
Product ID
63629-9109_f322be76-93f3-42e0-9435-9ce0605cd2ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075269
Marketing category
ANDA
Marketing start
2012-10-18
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

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
63629-9109-1Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE300101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9109NIFEDIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20230217_59724871-b495-4911-a86d-20069ec42edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN59724871-b495-4911-a86d-20069ec42edd101
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD59724871-b495-4911-a86d-20069ec42edd101
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY59724871-b495-4911-a86d-20069ec42edd101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9109-163629910901300 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-9109-1) 2023-02-16NoNoCurrent