FDA.reportPublic FDA data

nifedipine

Product NDC
68682-109
11-digit product format
686820109
Labeler code
68682
Product ID
68682-109_68cca98c-658a-48b4-9630-478b62b1471e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nifedipine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA075289
Marketing category
ANDA
Marketing start
2000-09-27
Substance
NIFEDIPINE
Active strength
60 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
NIFEDIPINE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui1812011, 1812013

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
68682-109-10nifedipine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1007
68682-109-30nifedipine300 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-109-10EA - Each68682-1098a0556c4-f55a-48c4-b5f2-b3d97dfa6c2a12017-03-06
68682-109-30EA - Each68682-10974f3f70b-b9d8-480c-824c-adec65632bb012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-109NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20200114_c7874606-c71e-424c-b881-38697988e0d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSNc7874606-c71e-424c-b881-38697988e0d07
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNc7874606-c71e-424c-b881-38697988e0d07
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCDc7874606-c71e-424c-b881-38697988e0d07
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDc7874606-c71e-424c-b881-38697988e0d07
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSYc7874606-c71e-424c-b881-38697988e0d07
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYc7874606-c71e-424c-b881-38697988e0d07
1812013NIFEdipine 60 MG Osmotic 24HR Extended Release Oral TabletPSNd7475c68-6310-4b9a-81c1-9209a9ade75f3
1812013Osmotic 24 HR nifedipine 60 MG Extended Release Oral TabletSCDd7475c68-6310-4b9a-81c1-9209a9ade75f3
1812013nifedipine 60 MG Osmotic 24 HR Extended Release Oral TabletSYd7475c68-6310-4b9a-81c1-9209a9ade75f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-109-1068682010910100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10) 2000-09-270000-00-00NoNoCurrent
68682-109-3068682010930300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30) 2000-09-270000-00-00NoNoCurrent