FDA.reportPublic FDA data

Nifedipine

Product NDC
68382-686
11-digit product format
683820686
Labeler code
68382
Product ID
68382-686_c0025ef1-99d7-4b31-9d99-4be010b2b9fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA210012
Marketing category
ANDA
Marketing start
2018-02-02
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
Rxcui1812011, 1812013, 1812015

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
68382-686-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
68382-686-10Nifedipine1000 in 1 BOTTLETABLET, EXTENDED RELEASE10005
68382-686-95Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-686NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 3 package rows20241212_657221d5-9eb8-42f9-8cdc-39cefc386f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN657221d5-9eb8-42f9-8cdc-39cefc386f515
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN657221d5-9eb8-42f9-8cdc-39cefc386f515
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSN657221d5-9eb8-42f9-8cdc-39cefc386f515
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD657221d5-9eb8-42f9-8cdc-39cefc386f515
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD657221d5-9eb8-42f9-8cdc-39cefc386f515
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCD657221d5-9eb8-42f9-8cdc-39cefc386f515
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY657221d5-9eb8-42f9-8cdc-39cefc386f515
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY657221d5-9eb8-42f9-8cdc-39cefc386f515
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSY657221d5-9eb8-42f9-8cdc-39cefc386f515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-686-0168382068601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-01) 2018-02-020000-00-00NoNoCurrent
68382-686-10683820686101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-10) 2018-02-020000-00-00NoNoCurrent
68382-686-9568382068695300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-95) 2018-02-020000-00-00NoNoCurrent