FDA.reportPublic FDA data

Nifedipine

Product NDC
50090-5284
11-digit product format
500905284
Labeler code
50090
Product ID
50090-5284_cd9aaa14-e9ae-4307-b837-be45f047b65d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075269
Marketing category
ANDA
Marketing start
2012-10-18
Substance
NIFEDIPINE
Active strength
30 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
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198034

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5284-02023-02-07C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg
50090-5284-12023-02-07C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg
50090-5284-22023-02-07C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg
50090-5284-02023-01-30C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg
50090-5284-12023-01-30C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg
50090-5284-22023-01-30C16284748780-1f386c649-9b78-0266-e053-dadaa90a7c1aNifedipine Extended-Release Tablets, USP 30 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5284-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
50090-5284-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE10010
50090-5284-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5284-0EA - Each50090-5284a5f88a04-d235-47b2-b346-bde82ce8024412023-04-07
50090-5284-1EA - Each50090-52842fdf78cc-4cbd-4cb8-a0b0-35cfeafb1b0112023-04-07
50090-5284-2EA - Each50090-52841c536981-d01a-4a6f-b9a5-76e3469fbb4212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5284NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 3 package rows20230317_af5a6330-1819-4724-9f08-da45ac9fb478.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNaf5a6330-1819-4724-9f08-da45ac9fb47810
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDaf5a6330-1819-4724-9f08-da45ac9fb47810
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYaf5a6330-1819-4724-9f08-da45ac9fb47810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5284-05009052840030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5284-0) 2020-10-220000-00-00NoNoCurrent
50090-5284-150090528401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5284-1) 2020-10-220000-00-00NoNoCurrent
50090-5284-25009052840290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5284-2) 2020-10-220000-00-00NoNoCurrent