FDA.reportPublic FDA data

NIFEDIPINE

Product NDC
68382-689
11-digit product format
683820689
Labeler code
68382
Product ID
68382-689_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIFEDIPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA210184
Marketing category
ANDA
Marketing start
2018-08-18
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
Rxcui198034, 198035, 198036

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
68382-689-01NIFEDIPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
68382-689-10NIFEDIPINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
68382-689-16NIFEDIPINE90 in 1 BOTTLETABLET, EXTENDED RELEASE904
68382-689-77NIFEDIPINE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
68382-689-77NIFEDIPINE10 in 1 CARTONTABLET, EXTENDED RELEASE104
68382-689-95NIFEDIPINE300 in 1 BOTTLETABLET, EXTENDED RELEASE3004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-689NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 6 package rows20240118_1c857df2-9cce-40de-95c3-b1274ed1e1bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN1c857df2-9cce-40de-95c3-b1274ed1e1bc4
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN1c857df2-9cce-40de-95c3-b1274ed1e1bc4
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN1c857df2-9cce-40de-95c3-b1274ed1e1bc4
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD1c857df2-9cce-40de-95c3-b1274ed1e1bc4
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD1c857df2-9cce-40de-95c3-b1274ed1e1bc4
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD1c857df2-9cce-40de-95c3-b1274ed1e1bc4
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY1c857df2-9cce-40de-95c3-b1274ed1e1bc4
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY1c857df2-9cce-40de-95c3-b1274ed1e1bc4
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY1c857df2-9cce-40de-95c3-b1274ed1e1bc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-689-0168382068901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-01) 2018-08-180000-00-00NoNoCurrent
68382-689-10683820689101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-10) 2018-08-180000-00-00NoNoCurrent
68382-689-166838206891690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-16) 2018-08-180000-00-00NoNoCurrent
68382-689-776838206897710 BLISTER PACK in 1 CARTON (68382-689-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-08-180000-00-00NoNoCurrent
68382-689-9568382068995300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-95) 2018-08-180000-00-00NoNoCurrent