FDA.reportPublic FDA data

Nifedipine

Product NDC
50742-262
11-digit product format
507420262
Labeler code
50742
Product ID
50742-262_2d798366-5fb6-4ea5-b1cc-663a0c3290b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
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
Rxcui1812011, 1812013, 1812015

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
50742-262-01Nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
50742-262-03Nifedipine300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3006
50742-262-30Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-262NIFEDIPINE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20230207_4d3e11d2-d320-45d3-96c8-48322202b504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY71a4e00b-8386-4da1-8515-a0e7e8db104d102
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN4d3e11d2-d320-45d3-96c8-48322202b5046
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD4d3e11d2-d320-45d3-96c8-48322202b5046
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY4d3e11d2-d320-45d3-96c8-48322202b5046
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY9f64a8d7-dfbf-4a81-81bd-b09cfe7cbd443
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 startMarketing endSampleExclude flagStatus
50742-262-0150742026201100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-01) 2019-03-120000-00-00NoNoCurrent
50742-262-0350742026203300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-03) 2019-03-120000-00-00NoNoCurrent
50742-262-305074202623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-262-30) 2019-03-120000-00-00NoNoCurrent