FDA.reportPublic FDA data

Nifedipine

Product NDC
68682-106
11-digit product format
686820106
Labeler code
68682
Product ID
68682-106_2c9ac184-8e21-479c-a1e8-4abeadfb54a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA075269
Marketing category
ANDA
Marketing start
2000-12-04
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
Rxcui198035

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68682-106-10Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
68682-106-30Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-106-10EA - Each68682-106398460de-6169-42a7-8552-e890e5fe3bb612016-05-16
68682-106-30EA - Each68682-10617c185db-dbe8-4771-921d-2f61423fa5c312016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-106NIFEDIPINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20200114_fb6d8f32-198e-4ccf-bf25-069c03d624fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN0b4e9bbc-4c16-4611-9ea2-903852804227101
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD0b4e9bbc-4c16-4611-9ea2-903852804227101
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY0b4e9bbc-4c16-4611-9ea2-903852804227101
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSNfb6d8f32-198e-4ccf-bf25-069c03d624fd7
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCDfb6d8f32-198e-4ccf-bf25-069c03d624fd7
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSYfb6d8f32-198e-4ccf-bf25-069c03d624fd7
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN81e6c8e7-e826-4abb-ad58-1dee62091a664
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD81e6c8e7-e826-4abb-ad58-1dee62091a664
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY81e6c8e7-e826-4abb-ad58-1dee62091a664
198035NIFEdipine 60 MG 24HR Extended Release Oral TabletPSN61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
19803524 HR nifedipine 60 MG Extended Release Oral TabletSCD61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1
198035nifedipine 60 MG 24 HR Extended Release Oral TabletSY61eff839-7c98-4d49-bfb2-cb67b5dc5f6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-106-1068682010610100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-10) 2000-12-040000-00-00NoNoCurrent
68682-106-3068682010630300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-106-30) 2000-12-040000-00-00NoNoCurrent