FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-6767
11-digit product format
500906767
Labeler code
50090
Product ID
50090-6767_db03e3bc-412a-4336-a97c-dbcdb4bbc1bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
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
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
50090-6767-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-6767-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1003
50090-6767-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6767-0EA - Each50090-6767c34d8501-8557-47a7-a86f-799bc9d50c3712023-12-05
50090-6767-1EA - Each50090-67679c3ba156-84c9-42c5-a6b9-95c8d63f7d1012023-12-05
50090-6767-2EA - Each50090-6767feb9a991-629c-40bd-84e1-f870de38f3f712023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6767NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20231031_4a4d5b67-6ce7-4098-9324-f68084e800e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN4a4d5b67-6ce7-4098-9324-f68084e800e43
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD4a4d5b67-6ce7-4098-9324-f68084e800e43
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY4a4d5b67-6ce7-4098-9324-f68084e800e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6767-05009067670030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-0) 2023-10-20NoNoCurrent
50090-6767-150090676701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-1) 2023-10-20NoNoCurrent
50090-6767-25009067670290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-2) 2023-10-20NoNoCurrent