FDA.reportPublic FDA data

Nifedipine

Product NDC
67877-758
11-digit product format
678770758
Labeler code
67877
Product ID
67877-758_2833cb85-4017-41e2-aa4a-c19371ba85e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA216067
Marketing category
ANDA
Marketing start
2022-03-30
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bbd94e90-e531-9113-45c1-29860f331640Product name720230104
5e4d0a9b-8ce4-418c-bf0c-d2b4be281ffdProduct name420220126
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
308fd2ea-d88a-e021-96c1-7c2ab74d6e4bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-758-01Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
67877-758-05Nifedipine500 in 1 BOTTLETABLET, EXTENDED RELEASE50010
67877-758-58Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE30010
67877-758-90Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-758-01EA - Each67877-758d06899dd-003c-4439-bf5f-37e3682f81f312022-06-06
67877-758-58EA - Each67877-7580f8d0f32-dfcb-4abe-b60e-4ca5c1ce9d9f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-758NIFEDIPINE TABLET, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]9Current NDC, Legacy NDC, 4 package rows20230523_f661c1d9-f0f6-4595-82dd-f656bff974f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN7160331a-8735-4bc0-8cb9-a8014512a66913
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD7160331a-8735-4bc0-8cb9-a8014512a66913
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY7160331a-8735-4bc0-8cb9-a8014512a66913
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNf661c1d9-f0f6-4595-82dd-f656bff974f110
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNf661c1d9-f0f6-4595-82dd-f656bff974f110
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNf661c1d9-f0f6-4595-82dd-f656bff974f110
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDf661c1d9-f0f6-4595-82dd-f656bff974f110
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDf661c1d9-f0f6-4595-82dd-f656bff974f110
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDf661c1d9-f0f6-4595-82dd-f656bff974f110
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYf661c1d9-f0f6-4595-82dd-f656bff974f110
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYf661c1d9-f0f6-4595-82dd-f656bff974f110
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYf661c1d9-f0f6-4595-82dd-f656bff974f110
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSN4a4d5b67-6ce7-4098-9324-f68084e800e43
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCD4a4d5b67-6ce7-4098-9324-f68084e800e43
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSY4a4d5b67-6ce7-4098-9324-f68084e800e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-758-0167877075801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-01) 2022-03-300000-00-00NoNoCurrent
67877-758-0567877075805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-05) 2022-03-300000-00-00NoNoCurrent
67877-758-5867877075858300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-58) 2022-03-300000-00-00NoNoCurrent
67877-758-906787707589090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-90) 2022-03-300000-00-00NoNoCurrent