FDA.reportPublic FDA data

Nifedipine

Product NDC
68788-7642
11-digit product format
687887642
Labeler code
68788
Product ID
68788-7642_902d31db-8e45-4221-9308-2f02ea622a4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA210614
Marketing category
ANDA
Marketing start
2020-02-28
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
68788-7642-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1006
68788-7642-3Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE306
68788-7642-6Nifedipine60 in 1 BOTTLETABLET, EXTENDED RELEASE606
68788-7642-9Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7642NIFEDIPINE TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240724_4ee466dc-5a4e-4c77-8e94-8b510cafd61b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN4ee466dc-5a4e-4c77-8e94-8b510cafd61b6
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD4ee466dc-5a4e-4c77-8e94-8b510cafd61b6
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY4ee466dc-5a4e-4c77-8e94-8b510cafd61b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7642-168788764201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7642-1) 2020-02-280000-00-00NoNoCurrent
68788-7642-36878876420330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7642-3) 2020-02-280000-00-00NoNoCurrent
68788-7642-66878876420660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7642-6) 2020-02-280000-00-00NoNoCurrent
68788-7642-96878876420990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7642-9) 2020-02-280000-00-00NoNoCurrent