FDA.reportPublic FDA data

Nifedipine

Product NDC
71335-1721
11-digit product format
713351721
Labeler code
71335
Product ID
71335-1721_22531798-9055-4e73-b8cb-58dce32eb3b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
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
71335-1721-1Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
71335-1721-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE90103
71335-1721-3Nifedipine60 in 1 BOTTLETABLET, EXTENDED RELEASE60103
71335-1721-4Nifedipine28 in 1 BOTTLETABLET, EXTENDED RELEASE28103
71335-1721-5Nifedipine10 in 1 BOTTLETABLET, EXTENDED RELEASE10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1721NIFEDIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20250330_e1cd5011-b80e-4b1b-8729-56260b8b3c26.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1721-17133517210130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1721-1) 2020-11-090000-00-00NoNoCurrent
71335-1721-27133517210290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1721-2) 2020-11-090000-00-00NoNoCurrent
71335-1721-37133517210360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1721-3) 2020-11-090000-00-00NoNoCurrent
71335-1721-47133517210428 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1721-4) 2020-11-090000-00-00NoNoCurrent
71335-1721-57133517210510 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1721-5) 2020-11-09NoNoHistorical