Nifedipine

Product NDC
71610-055
11-digit product format
716100055
Labeler code
71610
Product ID
71610-055_9ac260ce-89b0-4218-9215-5e3ba9cba03f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076070
Marketing category
ANDA
Marketing start
2002-08-16
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
Rxcui198036

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
71610-055-60Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-055-60EA - Each71610-0557362839d-d6b5-4707-b977-6e027156e87212018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-055NIFEDIPINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 1 package rows20180509_36b07283-fc0e-4a14-b78f-1d2ab80e7f31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN36b07283-fc0e-4a14-b78f-1d2ab80e7f311
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD36b07283-fc0e-4a14-b78f-1d2ab80e7f311
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY36b07283-fc0e-4a14-b78f-1d2ab80e7f311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-055-607161000556090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-055-60) 2018-05-020000-00-00NoNoCurrent