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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-603-11EA - Each68084-603d8556926-7c55-4eb4-bcd2-96cc727d6ef512012-07-24
68084-603-21EA - Each68084-6035ea836b5-5719-464d-9074-f7ea335c357212012-07-24
68084-603-65EA - Each68084-603032597bd-ff9f-4931-9061-7d3bd6c5c09a12023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIFEDIPINEACTIVE INGREDIENTI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
NIFEDIPINEACTIVE MOIETYI9ZF7L6G2LNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ENIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2
TRIACETININACTIVE INGREDIENTXHX3C3X673NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]2

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