Nifedipine

Product NDC
72162-2260
11-digit product format
721622260
Labeler code
72162
Product ID
72162-2260_49efb84f-c70f-4e63-aa0f-82a6acbd9665
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198035

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72162-2260-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE100101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2260-1EA - Each72162-22604b989be9-9a58-42f1-9ea1-f1076a39c90c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2260NIFEDIPINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240224_0b4e9bbc-4c16-4611-9ea2-903852804227.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN0b4e9bbc-4c16-4611-9ea2-903852804227101
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD0b4e9bbc-4c16-4611-9ea2-903852804227101
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY0b4e9bbc-4c16-4611-9ea2-903852804227101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2260-172162226001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-2260-1) 2000-12-04NoNoHistorical