FDA.reportPublic FDA data

Nifedipine

Product NDC
71610-012
11-digit product format
716100012
Labeler code
71610
Product ID
71610-012_15325d8c-d716-9819-e063-6294a90a06d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075269
Marketing category
ANDA
Marketing start
2000-12-04
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
Rxcui198035

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
71610-012-04Nifedipine4000 in 1 BOTTLETABLET, EXTENDED RELEASE40004
71610-012-16Nifedipine6000 in 1 BOTTLETABLET, EXTENDED RELEASE60004
71610-012-60Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE904
71610-012-80Nifedipine180 in 1 BOTTLETABLET, EXTENDED RELEASE1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-012-04EA - Each71610-012c4318f2c-7ff9-4ee0-973d-2e8e2bff7bd812024-05-16
71610-012-16EA - Each71610-0121e3dbdcf-e9e1-4fd2-9100-e7d94efcb13612021-11-09
71610-012-30EA - Each71610-01262dda764-3350-4278-96f2-7b443a569fc312018-03-08
71610-012-60EA - Each71610-0128076ec35-c8ee-4a96-a289-20bd09e28df212018-03-08
71610-012-80EA - Each71610-0122e3ad28a-16e2-4668-8e6c-fd18acce459512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-012NIFEDIPINE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 4 package rows20240407_81e6c8e7-e826-4abb-ad58-1dee62091a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN81e6c8e7-e826-4abb-ad58-1dee62091a664
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD81e6c8e7-e826-4abb-ad58-1dee62091a664
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY81e6c8e7-e826-4abb-ad58-1dee62091a664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-012-04716100012044000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04) 2024-04-02NoNoCurrent
71610-012-16716100012166000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16) 2021-09-200000-00-00NoNoCurrent
71610-012-307161000123030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-30) 2017-11-170000-00-00NoNoCurrent
71610-012-607161000126090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60) 2017-11-150000-00-00NoNoCurrent
71610-012-8071610001280180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80) 2019-05-01NoNoCurrent