FDA.reportPublic FDA data

Gabapentin

Product NDC
71610-463
11-digit product format
716100463
Labeler code
71610
Product ID
71610-463_0058d01d-82c9-46aa-8de0-d4528fc54b71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-02-04
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-463-302023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-452023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-532023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-602023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-702023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-732023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-802023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993
71610-463-922023-01-30C16284748780-1f386c649-bbda-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 tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-463-30Gabapentin30 in 1 BOTTLETABLET302
71610-463-45Gabapentin45 in 1 BOTTLETABLET452
71610-463-53Gabapentin60 in 1 BOTTLETABLET602
71610-463-60Gabapentin90 in 1 BOTTLETABLET902
71610-463-70Gabapentin120 in 1 BOTTLETABLET1202
71610-463-73Gabapentin135 in 1 BOTTLETABLET1352
71610-463-80Gabapentin180 in 1 BOTTLETABLET1802
71610-463-92Gabapentin270 in 1 BOTTLETABLET2702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-463GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 8 package rows20201114_0b917c7a-e2d0-4a76-be4c-134eb5550c0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN0b917c7a-e2d0-4a76-be4c-134eb5550c0d2
310433gabapentin 600 MG Oral TabletSCD0b917c7a-e2d0-4a76-be4c-134eb5550c0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-463-307161004633030 TABLET in 1 BOTTLE (71610-463-30) 30 tablet2020-09-090000-00-00NoNoCurrent
71610-463-457161004634545 TABLET in 1 BOTTLE (71610-463-45) 45 tablet2020-09-090000-00-00NoNoCurrent
71610-463-537161004635360 TABLET in 1 BOTTLE (71610-463-53) 60 tablet2020-09-090000-00-00NoNoCurrent
71610-463-607161004636090 TABLET in 1 BOTTLE (71610-463-60) 90 tablet2020-10-150000-00-00NoNoCurrent
71610-463-7071610046370120 TABLET in 1 BOTTLE (71610-463-70) 120 tablet2020-09-090000-00-00NoNoCurrent
71610-463-7371610046373135 TABLET in 1 BOTTLE (71610-463-73) 135 tablet2020-09-090000-00-00NoNoCurrent
71610-463-8071610046380180 TABLET in 1 BOTTLE (71610-463-80) 180 tablet2020-09-090000-00-00NoNoCurrent
71610-463-9271610046392270 TABLET in 1 BOTTLE (71610-463-92) 270 tablet2020-09-090000-00-00NoNoCurrent