FDA.reportPublic FDA data

Gabapentin

Product NDC
67046-238
11-digit product format
670460238
Labeler code
67046
Product ID
67046-238_5a05a77b-ab0e-d3f8-e053-2a91aa0a906f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA202764
Marketing category
ANDA
Marketing start
2017-09-25
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
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
67046-238-072020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-142020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-152020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-202020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-212020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-282020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-302020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993
67046-238-602020-01-31C16284748780-19d75b9d0-6112-f424-e053-dadaa90a57ce234 Gabapentin 600 mg 238 Gabapentin 800 mg These highlights do not include all the information needed to use gabapentin tablets, USP safely and effectively. See full prescribing information for gabapentin tablets, USP GABAPENTIN Tablets, USP for Oral Use Initial U.S. Approval:1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-238-07Gabapentin7 in 1 BLISTER PACKTABLET71
67046-238-14Gabapentin14 in 1 BLISTER PACKTABLET141
67046-238-15Gabapentin15 in 1 BLISTER PACKTABLET151
67046-238-20Gabapentin20 in 1 BLISTER PACKTABLET201
67046-238-21Gabapentin21 in 1 BLISTER PACKTABLET211
67046-238-28Gabapentin28 in 1 BLISTER PACKTABLET281
67046-238-30Gabapentin30 in 1 BLISTER PACKTABLET301
67046-238-60Gabapentin60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-238GABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170925_5a05a77b-ab0d-d3f8-e053-2a91aa0a906f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310434gabapentin 800 MG Oral TabletPSN5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310433gabapentin 600 MG Oral TabletSCD5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1
310434gabapentin 800 MG Oral TabletSCD5a05a77b-ab0d-d3f8-e053-2a91aa0a906f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-238-07670460238077 in 1 BLISTER PACKHistorical
67046-238-146704602381414 in 1 BLISTER PACKHistorical
67046-238-156704602381515 in 1 BLISTER PACKHistorical
67046-238-206704602382020 in 1 BLISTER PACKHistorical
67046-238-216704602382121 in 1 BLISTER PACKHistorical
67046-238-286704602382828 in 1 BLISTER PACKHistorical
67046-238-306704602383030 in 1 BLISTER PACKHistorical
67046-238-606704602386060 in 1 BLISTER PACKHistorical