FDA.reportPublic FDA data

Nifedipine

Product NDC
68682-105
11-digit product format
686820105
Labeler code
68682
Product ID
68682-105_ed2ab44d-7e6a-4c65-8bb0-9d3a4d9bf618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nifedipine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
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
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
Rxcui198034

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
68682-105-10Nifedipine100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
68682-105-30Nifedipine300 in 1 BOTTLETABLET, EXTENDED RELEASE3009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-105-10EA - Each68682-1054854ab13-f1e6-4d7f-a399-5c623ca45dfc12016-05-16
68682-105-30EA - Each68682-10500185344-29ee-4124-af3b-da46de3f735112016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-105NIFEDIPINE TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20200114_cb051508-60f3-4b89-9da0-5261024bd7f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN59724871-b495-4911-a86d-20069ec42edd101
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNcb9d013a-2303-4e1d-a539-8ff04d5ec91d101
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD59724871-b495-4911-a86d-20069ec42edd101
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDcb9d013a-2303-4e1d-a539-8ff04d5ec91d101
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYcb9d013a-2303-4e1d-a539-8ff04d5ec91d101
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY59724871-b495-4911-a86d-20069ec42edd101
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
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNcb051508-60f3-4b89-9da0-5261024bd7f49
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDcb051508-60f3-4b89-9da0-5261024bd7f49
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYcb051508-60f3-4b89-9da0-5261024bd7f49
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSNd9dec600-4e11-8292-e053-2a95a90a68423
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCDd9dec600-4e11-8292-e053-2a95a90a68423
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSYd9dec600-4e11-8292-e053-2a95a90a68423
198034NIFEdipine 30 MG 24HR Extended Release Oral TabletPSN95a53fc5-852d-4892-af20-2aaece9399ba1
1812011NIFEdipine 30 MG Osmotic 24HR Extended Release Oral TabletPSN1e1b6670-badc-a933-e063-6394a90a3a471
19803424 HR nifedipine 30 MG Extended Release Oral TabletSCD95a53fc5-852d-4892-af20-2aaece9399ba1
1812011Osmotic 24 HR nifedipine 30 MG Extended Release Oral TabletSCD1e1b6670-badc-a933-e063-6394a90a3a471
198034nifedipine 30 MG 24 HR Extended Release Oral TabletSY95a53fc5-852d-4892-af20-2aaece9399ba1
1812011nifedipine 30 MG Osmotic 24 HR Extended Release Oral TabletSY1e1b6670-badc-a933-e063-6394a90a3a471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-105-1068682010510100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-105-10) 2012-10-180000-00-00NoNoCurrent
68682-105-3068682010530300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-105-30) 2012-10-180000-00-00NoNoCurrent