FDA.reportPublic FDA data

Nifedipine

Product NDC
72789-485
11-digit product format
727890485
Labeler code
72789
Product ID
72789-485_48387f23-9c80-d037-e063-6294a90a1ae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA216067
Marketing category
ANDA
Marketing start
2022-03-30
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
Rxcui1812013

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
72789-485-01Nifedipine100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10013
72789-485-87Nifedipine300 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-485-01EA - Each72789-485df5c3435-ae46-433e-aad2-73e9d95dbb8e12025-03-04
72789-485-87EA - Each72789-48575c53fed-9dd9-4555-b732-a4232f29e3f912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-485NIFEDIPINE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]11Current NDC, 2 package rows20250215_7160331a-8735-4bc0-8cb9-a8014512a669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN7160331a-8735-4bc0-8cb9-a8014512a66913
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD7160331a-8735-4bc0-8cb9-a8014512a66913
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY7160331a-8735-4bc0-8cb9-a8014512a66913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-485-0172789048501100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-01) 2025-02-12NoNoCurrent
72789-485-8772789048587300 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-87) 2025-02-10NoNoCurrent