Nifedipine

Product NDC
0904-7229
11-digit product format
009047229
Labeler code
0904
Product ID
0904-7229_4f81130b-db75-4292-9229-338914ccd6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202644
Marketing category
ANDA
Marketing start
2022-08-23
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
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
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
0904-7229-61Nifedipine1 in 1 BLISTER PACKCAPSULE13
0904-7229-61Nifedipine100 in 1 CARTONCAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7229-61EA - Each0904-722945d5495e-2200-48c2-a452-37e2803e872912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7229NIFEDIPINE CAPSULE [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250305_acb493a3-b8f2-41a9-8ab2-550d97c4592a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSNacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032nifedipine 10 MG Oral CapsuleSCDacb493a3-b8f2-41a9-8ab2-550d97c4592a3
198032NIFEdipine 10 MG Oral CapsulePSN472621b6-c2b7-4582-9ceb-7cead55ff2471
198032nifedipine 10 MG Oral CapsuleSCD472621b6-c2b7-4582-9ceb-7cead55ff2471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7229-6100904722961100 BLISTER PACK in 1 CARTON (0904-7229-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2022-08-230000-00-00NoNoCurrent