FDA.reportPublic FDA data

Nifedipine

Product NDC
50742-261
11-digit product format
507420261
Labeler code
50742
Product ID
50742-261_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
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
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
50742-261-01Nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
50742-261-03Nifedipine300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3006
50742-261-30Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-261NIFEDIPINE 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
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNe1cd5011-b80e-4b1b-8729-56260b8b3c26103
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDe1cd5011-b80e-4b1b-8729-56260b8b3c26103
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYe1cd5011-b80e-4b1b-8729-56260b8b3c26103
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
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN446505e8-cd68-4037-bebe-954a893dc67b5
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD446505e8-cd68-4037-bebe-954a893dc67b5
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY446505e8-cd68-4037-bebe-954a893dc67b5
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNcda16a27-f029-40a6-a0e8-2bed0de711694
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN832fc274-605a-4b04-b327-dbf3611316214
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD832fc274-605a-4b04-b327-dbf3611316214
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDcda16a27-f029-40a6-a0e8-2bed0de711694
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYcda16a27-f029-40a6-a0e8-2bed0de711694
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY832fc274-605a-4b04-b327-dbf3611316214
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN1ab8945b-bea5-9827-e063-6294a90af3342
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNf8358be1-848c-d9eb-e053-6294a90a178c2
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD1ab8945b-bea5-9827-e063-6294a90af3342
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDf8358be1-848c-d9eb-e053-6294a90a178c2
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYf8358be1-848c-d9eb-e053-6294a90a178c2
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY1ab8945b-bea5-9827-e063-6294a90af3342
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN26b8f126-126b-4e31-e063-6394a90ae7241
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN0cabe053-3b7e-4dcb-8441-ef7821bb6f681
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD26b8f126-126b-4e31-e063-6394a90ae7241
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD0cabe053-3b7e-4dcb-8441-ef7821bb6f681
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY26b8f126-126b-4e31-e063-6394a90ae7241
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY0cabe053-3b7e-4dcb-8441-ef7821bb6f681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-261-0150742026101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-261-01) 2019-03-120000-00-00NoNoCurrent
50742-261-0350742026103300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-261-03) 2019-03-120000-00-00NoNoCurrent
50742-261-305074202613030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50742-261-30) 2019-03-120000-00-00NoNoCurrent