FDA.reportPublic FDA data

Gabapentin

Product NDC
10135-646
11-digit product format
101350646
Labeler code
10135
Product ID
10135-646_d129a366-3232-6c0f-e053-2995a90ac6d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA204989
Marketing category
ANDA
Marketing start
2018-04-01
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-646-012023-01-30C16284748780-1f386c64a-1434-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93
10135-646-052023-01-30C16284748780-1f386c64a-1434-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN safely and effectively. See full prescribing information for GABAPENTIN . GABAPENTIN capsules, for oral use GABAPENTIN t ablets, for oral use Initial U.S. Approval: 19 93

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-646-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1004
10135-646-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-646-01EA - Each10135-64698962de2-fa28-4190-9db0-77eb17c5562212021-12-08
10135-646-05EA - Each10135-646ff0ed937-4907-4cf2-83a4-c8ae1118a60c12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-646GABAPENTIN CAPSULE [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20211121_8fbbd062-ba6f-4c87-b215-21b0b946c73f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN8fbbd062-ba6f-4c87-b215-21b0b946c73f4
310431gabapentin 300 MG Oral CapsulePSN8fbbd062-ba6f-4c87-b215-21b0b946c73f4
310432gabapentin 400 MG Oral CapsulePSN8fbbd062-ba6f-4c87-b215-21b0b946c73f4
310430gabapentin 100 MG Oral CapsuleSCD8fbbd062-ba6f-4c87-b215-21b0b946c73f4
310431gabapentin 300 MG Oral CapsuleSCD8fbbd062-ba6f-4c87-b215-21b0b946c73f4
310432gabapentin 400 MG Oral CapsuleSCD8fbbd062-ba6f-4c87-b215-21b0b946c73f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-646-0110135064601100 CAPSULE in 1 BOTTLE, PLASTIC (10135-646-01) 100 capsule2018-04-010000-00-00NoNoCurrent
10135-646-0510135064605500 CAPSULE in 1 BOTTLE, PLASTIC (10135-646-05) 500 capsule2018-04-010000-00-00NoNoCurrent
10135-646-301013506463030 CAPSULE in 1 BOTTLE, PLASTIC (10135-646-30) 30 capsule2018-04-010000-00-00NoNoCurrent