FDA.reportPublic FDA data

Nifedipine

Product NDC
68084-603
11-digit product format
680840603
Labeler code
68084
Product ID
68084-603_35460830-1534-dc42-e063-6394a90a1e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077127
Marketing category
ANDA
Marketing start
2012-08-21
Substance
NIFEDIPINE
Active strength
90 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
NIFEDIPINE90 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
68084-603-11Nifedipine1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE110
68084-603-21Nifedipine30 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE3010
68084-603-65Nifedipine50 in 1 CARTONTABLET, FILM COATED, EXTENDED RE5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-603NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]10Current NDC, Legacy NDC, 3 package rows20250522_b11026f8-dea0-49ac-8725-0ef7dc27923f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYb11026f8-dea0-49ac-8725-0ef7dc27923f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-603-11680840603111 in 1 BLISTER PACKHistorical
68084-603-216808406032130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-603-21) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-603-11) 30 blister pack2012-08-210000-00-00NoNoCurrent
68084-603-656808406036550 BLISTER PACK in 1 CARTON (68084-603-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-603-11) 50 blister pack2023-02-06NoNoCurrent