Nifedipine

Product NDC
51655-407
11-digit product format
516550407
Labeler code
51655
Product ID
51655-407_48fefe2e-81a8-d021-e063-6394a90a12fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA210614
Marketing category
ANDA
Marketing start
2022-10-27
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
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
NIFEDIPINE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812015

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
51655-407-52Nifedipine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-407NIFEDIPINE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241220_f2f3564a-d43a-6c36-e053-2a95a90ae878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812015NIFEdipine 90 MG Osmotic 24HR Extended Release Oral TabletPSNf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015Osmotic 24 HR nifedipine 90 MG Extended Release Oral TabletSCDf2f3564a-d43a-6c36-e053-2a95a90ae8784
1812015nifedipine 90 MG Osmotic 24 HR Extended Release Oral TabletSYf2f3564a-d43a-6c36-e053-2a95a90ae8784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-407-525165504075230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-407-52) 2022-10-27NoNoCurrent