Nifedipine

Product NDC
62135-740
11-digit product format
621350740
Labeler code
62135
Product ID
62135-740_462a6e34-b07c-965d-e063-6294a90ab52b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA202644
Marketing category
ANDA
Marketing start
2010-12-07
Substance
NIFEDIPINE
Active strength
20 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
NIFEDIPINE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198032, 198033

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
62135-740-90Nifedipine90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-740NIFEDIPINE CAPSULE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241025_5014847e-389d-48c1-8350-b9b24ca8d2a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN5014847e-389d-48c1-8350-b9b24ca8d2a43
198033NIFEdipine 20 MG Oral CapsulePSN5014847e-389d-48c1-8350-b9b24ca8d2a43
198032nifedipine 10 MG Oral CapsuleSCD5014847e-389d-48c1-8350-b9b24ca8d2a43
198033nifedipine 20 MG Oral CapsuleSCD5014847e-389d-48c1-8350-b9b24ca8d2a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-740-906213507409090 CAPSULE in 1 BOTTLE (62135-740-90) 90 capsule2023-08-08NoNoCurrent