Nifedipine

Product NDC
60760-862
11-digit product format
607600862
Labeler code
60760
Product ID
60760-862_4961231d-dbb9-9435-e063-6394a90a531f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
Substance
NIFEDIPINE
Active strength
90 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
NIFEDIPINE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812015

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
60760-862-90Nifedipine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-862NIFEDIPINE TABLET, EXTENDED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20240616_1add684f-d082-72cc-e063-6394a90a1214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN1add684f-d082-72cc-e063-6394a90a12142
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD1add684f-d082-72cc-e063-6394a90a12142
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY1add684f-d082-72cc-e063-6394a90a12142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-862-906076008629090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-862-90) 2024-06-04NoNoCurrent