Nifedipine

Product NDC
70518-4625
11-digit product format
705184625
Labeler code
70518
Product ID
70518-4625_503ac20c-0b86-83cf-e063-6294a90a0ee7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202644
Marketing category
ANDA
Marketing start
2026-04-24
Substance
NIFEDIPINE
Active strength
10 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
NIFEDIPINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198032

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
70518-4625-0Nifedipine50 in 1 BOXCAPSULE501
70518-4625-1Nifedipine1 in 1 POUCHCAPSULE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSNbddfd658-ac61-4ba2-a3fa-07acc35d368a1
198032nifedipine 10 MG Oral CapsuleSCDbddfd658-ac61-4ba2-a3fa-07acc35d368a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4625-07051846250050 POUCH in 1 BOX (70518-4625-0) / 1 CAPSULE in 1 POUCH (70518-4625-1) 50 pouch2026-04-24NoNoHistorical
70518-4625-1705184625011 in 1 POUCHHistorical