Nifedipine

Product NDC
50090-6203
11-digit product format
500906203
Labeler code
50090
Product ID
50090-6203_7716d3ae-4bb1-46ea-9d67-918b15dec3c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210614
Marketing category
ANDA
Marketing start
2019-03-12
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
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
NIFEDIPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011

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
50090-6203-0Nifedipine30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50090-6203-1Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
50090-6203-2Nifedipine90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6203-0EA - Each50090-62030a54e6f7-abaf-42ae-93aa-a919d827656012022-12-07
50090-6203-1EA - Each50090-620352d887aa-dc10-4160-be42-62469d9b55ae12022-12-07
50090-6203-2EA - Each50090-6203c701bfca-3350-4d1a-81c4-e957cf92f81d12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6203NIFEDIPINE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20231101_3334ab6f-aeb0-4b78-8d17-f0aedd94f996.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN3334ab6f-aeb0-4b78-8d17-f0aedd94f9965
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD3334ab6f-aeb0-4b78-8d17-f0aedd94f9965
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY3334ab6f-aeb0-4b78-8d17-f0aedd94f9965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6203-05009062030030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6203-0) 2022-11-030000-00-00NoNoCurrent
50090-6203-150090620301100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6203-1) 2022-11-030000-00-00NoNoCurrent
50090-6203-25009062030290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6203-2) 2022-11-030000-00-00NoNoCurrent