FDA.reportPublic FDA data

Nimodipine

Product NDC
67877-297
11-digit product format
678770297
Labeler code
67877
Product ID
67877-297_5752301d-2cfb-46cd-a9cf-86a8d6db2e28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Ascend Laboratories, LLC
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
2020-12-31
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 productproduct67877-297DDiscontinued by firm2026-07-31
excluded packagepackage67877-29767877-297-30DDiscontinued by firm2026-07-31
excluded packagepackage67877-29767877-297-38DDiscontinued 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c652b1c-164c-48c3-ae98-4d96fe16a1a2Product name120251114
d941181f-1f0c-c11b-5ab9-a359f0ca2e83Product name220250304
4b413d86-9489-373a-0c33-320b9817a388Product name320150731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-297-302024-01-30C16284748780-11030e365-52bb-111a-e063-dadaa90a10e2Nimodipine Capsules For Oral Use
67877-297-382024-01-30C16284748780-11030e365-52bb-111a-e063-dadaa90a10e2Nimodipine Capsules For Oral Use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-297-30Nimodipine30 in 1 PACKAGECAPSULE, LIQUID FILLED305
67877-297-38Nimodipine100 in 1 PACKAGECAPSULE, LIQUID FILLED1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIMODIPINEACTIVE INGREDIENT57WA9QZ5WHNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
NIMODIPINEACTIVE MOIETY57WA9QZ5WHNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
GELATININACTIVE INGREDIENT2G86QN327LNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RNIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]3
NIMODIPINEACTIVE INGREDIENT57WA9QZ5WHNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
NIMODIPINEACTIVE MOIETY57WA9QZ5WHNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2
WATERINACTIVE INGREDIENT059QF0KO0RNIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-297NIMODIPINE CAPSULE, LIQUID FILLED [ASCEND LABORATORIES, LLC]5Legacy NDC, 2 package rows20181218_2f4813da-931d-448d-bbe1-f0b90724af22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198037niMODipine 30 MG Oral CapsulePSN2f4813da-931d-448d-bbe1-f0b90724af225
198037nimodipine 30 MG Oral CapsuleSCD2f4813da-931d-448d-bbe1-f0b90724af225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-297-306787702973030 CAPSULE, LIQUID FILLED in 1 PACKAGE (67877-297-30) 2015-01-010000-00-00NoNoCurrent
67877-297-3867877029738100 CAPSULE, LIQUID FILLED in 1 PACKAGE (67877-297-38) 2015-01-010000-00-00NoNoCurrent