Nifedipine

Product NDC
72789-219
11-digit product format
727890219
Labeler code
72789
Product ID
72789-219_40ad017c-d405-29e8-e063-6294a90a6edc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202644
Marketing category
ANDA
Marketing start
2010-12-07
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
72789-219-08Nifedipine8 in 1 BOTTLE, PLASTICCAPSULE821

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-219-08EA - Each72789-219e0a26d47-ca8a-4a7f-87cb-826763cdd55d12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-219NIFEDIPINE CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 1 package rows20240217_51cdb22b-035f-47d7-8048-38006e2589f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198032NIFEdipine 10 MG Oral CapsulePSN51cdb22b-035f-47d7-8048-38006e2589f221
198032nifedipine 10 MG Oral CapsuleSCD51cdb22b-035f-47d7-8048-38006e2589f221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-219-08727890219088 CAPSULE in 1 BOTTLE, PLASTIC (72789-219-08) 8 capsule2021-12-150000-00-00NoNoCurrent