FDA.reportPublic FDA data

NIFEDIPINE

Product NDC
70771-1365
11-digit product format
707711365
Labeler code
70771
Product ID
70771-1365_b4ac4791-5cb1-4199-b56f-4171fd16fc33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NIFEDIPINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA210184
Marketing category
ANDA
Marketing start
2018-08-18
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
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
70771-1365-0NIFEDIPINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
70771-1365-1NIFEDIPINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
70771-1365-4NIFEDIPINE10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE104
70771-1365-4NIFEDIPINE10 in 1 CARTONTABLET, EXTENDED RELEASE104
70771-1365-5NIFEDIPINE500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
70771-1365-7NIFEDIPINE300 in 1 BOTTLETABLET, EXTENDED RELEASE3004
70771-1365-9NIFEDIPINE90 in 1 BOTTLETABLET, EXTENDED RELEASE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1365NIFEDIPINE TABLET, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20240118_925e2ea9-f51a-4b89-ab5d-ce590b6c4d85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY925e2ea9-f51a-4b89-ab5d-ce590b6c4d854
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY925e2ea9-f51a-4b89-ab5d-ce590b6c4d854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1365-0707711365001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1365-0) 2018-08-180000-00-00NoNoCurrent
70771-1365-170771136501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1365-1) 2018-08-180000-00-00NoNoCurrent
70771-1365-47077113650410 BLISTER PACK in 1 CARTON (70771-1365-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2018-08-180000-00-00NoNoCurrent
70771-1365-570771136505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1365-5) 2018-08-180000-00-00NoNoCurrent
70771-1365-770771136507300 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1365-7) 2018-08-180000-00-00NoNoCurrent
70771-1365-97077113650990 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1365-9) 2018-08-180000-00-00NoNoCurrent