FDA.reportPublic FDA data

Gabapentin

Product NDC
45865-549
11-digit product format
458650549
Labeler code
45865
Product ID
45865-549_7d63c12e-fc0b-6620-e053-2a91aa0a0732
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-549-302025-01-30C16284748780-12cef2736-5f24-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
45865-549-512025-01-30C16284748780-12cef2736-5f24-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
45865-549-602025-01-30C16284748780-12cef2736-5f24-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993
45865-549-902025-01-30C16284748780-12cef2736-5f24-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-549-30Gabapentin30 in 1 BOTTLECAPSULE301
45865-549-51Gabapentin120 in 1 BOTTLECAPSULE1201
45865-549-60Gabapentin60 in 1 BOTTLECAPSULE601
45865-549-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-549GABAPENTIN CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 4 package rows20181220_7d63c12e-fc0a-6620-e053-2a91aa0a0732.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN7d63c12e-fc0a-6620-e053-2a91aa0a07321
310430gabapentin 100 MG Oral CapsuleSCD7d63c12e-fc0a-6620-e053-2a91aa0a07321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-549-304586505493030 CAPSULE in 1 BOTTLE (45865-549-30) 30 capsule2018-06-010000-00-00NoNoCurrent
45865-549-5145865054951120 CAPSULE in 1 BOTTLE (45865-549-51) 120 capsule2018-06-010000-00-00NoNoCurrent
45865-549-604586505496060 CAPSULE in 1 BOTTLE (45865-549-60) 60 capsule2018-06-010000-00-00NoNoCurrent
45865-549-904586505499090 CAPSULE in 1 BOTTLE (45865-549-90) 90 capsule2018-06-010000-00-00NoNoCurrent