Nifedipine

Product NDC
51655-798
11-digit product format
516550798
Labeler code
51655
Product ID
51655-798_4973bdb9-ab5a-58eb-e063-6294a90a883e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075269
Marketing category
ANDA
Marketing start
2022-02-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nifedipine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198034

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
51655-798-26Nifedipine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-798NIFEDIPINE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20231219_d9dec600-4e11-8292-e053-2a95a90a6842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNd9dec600-4e11-8292-e053-2a95a90a68423
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDd9dec600-4e11-8292-e053-2a95a90a68423
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYd9dec600-4e11-8292-e053-2a95a90a68423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-798-265165507982690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-798-26) 2022-02-180000-00-00NoNoCurrent