Nifedipine

Product NDC
68682-107
11-digit product format
686820107
Labeler code
68682
Product ID
68682-107_8e94acd8-b4bb-4b2f-be6f-9783fd5e1d04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA076070
Marketing category
ANDA
Marketing start
2002-08-16
Substance
NIFEDIPINE
Active strength
90 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
NIFEDIPINE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9ZF7L6G2L
Rxcui198036

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
68682-107-10Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-107-10EA - Each68682-107512979e0-1832-47fd-ad1c-d10ec3e9cf7712016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-107NIFEDIPINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 1 package rows20200114_ca5b0178-4e5f-4077-ada5-7058b0a03858.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN888b3fac-2f2f-42b8-92d1-d37b6ed225a5101
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD888b3fac-2f2f-42b8-92d1-d37b6ed225a5101
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY888b3fac-2f2f-42b8-92d1-d37b6ed225a5101
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSNca5b0178-4e5f-4077-ada5-7058b0a038587
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCDca5b0178-4e5f-4077-ada5-7058b0a038587
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSYca5b0178-4e5f-4077-ada5-7058b0a038587
198036NIFEdipine 90 MG 24HR Extended Release Oral TabletPSN36b07283-fc0e-4a14-b78f-1d2ab80e7f311
19803624 HR nifedipine 90 MG Extended Release Oral TabletSCD36b07283-fc0e-4a14-b78f-1d2ab80e7f311
198036nifedipine 90 MG 24 HR Extended Release Oral TabletSY36b07283-fc0e-4a14-b78f-1d2ab80e7f311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-107-1068682010710100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-107-10) 2002-08-160000-00-00NoNoCurrent