Nimodipine

Product NDC
63739-797
11-digit product format
637390797
Labeler code
63739
Product ID
63739-797_bb148270-6d6f-7438-e053-2a95a90ace6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA090103
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
NIMODIPINE
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-797DDiscontinued by firm2026-07-31
excluded packagepackage63739-79763739-797-33DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090103-001NIMODIPINENIMODIPINE30MGCAPSULE / ORALAB2014-04-07

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A090103-001AB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-797-332020-07-22C16284748780-1ab0e2407-3154-f274-e053-dbdaa90a6471Nimodipine Capsules For Oral Use

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-797-33EA - Each63739-7976c18d72a-e5d6-41f4-9844-6ef4d9b1117f12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-797-33637390797333 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-797-33) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2016-12-290000-00-00NoNoCurrent