Nifedipine

Product NDC
63187-875
11-digit product format
631870875
Labeler code
63187
Product ID
63187-875_19b531f9-27f9-42e5-8c1e-7015c256bb22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077127
Marketing category
ANDA
Marketing start
2005-11-21
Substance
NIFEDIPINE
Active strength
30 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
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011

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
63187-875-30Nifedipine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
63187-875-60Nifedipine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
63187-875-90Nifedipine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-875-90EA - Each63187-8753ce541fb-ea1a-49be-a534-7c055986684012017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-875NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191113_4b6418a8-600f-470e-adf1-56207bb25c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN4b6418a8-600f-470e-adf1-56207bb25c383
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD4b6418a8-600f-470e-adf1-56207bb25c383
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY4b6418a8-600f-470e-adf1-56207bb25c383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-875-306318708753030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-30) 2017-07-030000-00-00NoNoCurrent
63187-875-606318708756060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-60) 2017-07-030000-00-00NoNoCurrent
63187-875-906318708759090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-875-90) 2017-07-030000-00-00NoNoCurrent