Nifedipine

Product NDC
21695-909
11-digit product format
216950909
Labeler code
21695
Product ID
21695-909_6fafbe75-fcae-4afd-9745-02e641cefb31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077899
Marketing category
ANDA
Marketing start
2006-12-13
Marketing end
0000-00-00
Substance
NIFEDIPINE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-909-302019-09-24C16284748780-1934fe258-48a5-48b1-e053-8cdaa90a720aNifedipine Extended-Release Tablets For Oral Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-909-30Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-909NIFEDIPINE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_6fafbe75-fcae-4afd-9745-02e641cefb31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN6fafbe75-fcae-4afd-9745-02e641cefb311
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD6fafbe75-fcae-4afd-9745-02e641cefb311
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY6fafbe75-fcae-4afd-9745-02e641cefb311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-909-302169509093030 in 1 BOTTLEHistorical