Gabapentin

Product NDC
67046-229
11-digit product format
670460229
Labeler code
67046
Product ID
67046-229_5a963df3-4c2c-71ce-e053-2a91aa0a1501
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077662
Marketing category
ANDA
Marketing start
2017-10-02
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
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
67046-229-072022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-142022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-152022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-202022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-212022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-282022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-302022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
67046-229-602022-01-28C16284748780-1d6a99b39-33d2-a426-e053-dadaa90af4c2229 Gabapentin 800 mg These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-229-07Gabapentin7 in 1 BLISTER PACKTABLET71
67046-229-14Gabapentin14 in 1 BLISTER PACKTABLET141
67046-229-15Gabapentin15 in 1 BLISTER PACKTABLET151
67046-229-20Gabapentin20 in 1 BLISTER PACKTABLET201
67046-229-21Gabapentin21 in 1 BLISTER PACKTABLET211
67046-229-28Gabapentin28 in 1 BLISTER PACKTABLET281
67046-229-30Gabapentin30 in 1 BLISTER PACKTABLET301
67046-229-60Gabapentin60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-229GABAPENTIN TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20171003_5a963df3-4c2b-71ce-e053-2a91aa0a1501.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN5a963df3-4c2b-71ce-e053-2a91aa0a15011
310434gabapentin 800 MG Oral TabletSCD5a963df3-4c2b-71ce-e053-2a91aa0a15011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-229-07670460229077 TABLET in 1 BLISTER PACK (67046-229-07) 7 tablet2017-10-020000-00-00NoNoCurrent
67046-229-146704602291414 TABLET in 1 BLISTER PACK (67046-229-14) 14 tablet2017-10-020000-00-00NoNoCurrent
67046-229-156704602291515 TABLET in 1 BLISTER PACK (67046-229-15) 15 tablet2017-10-020000-00-00NoNoCurrent
67046-229-206704602292020 TABLET in 1 BLISTER PACK (67046-229-20) 20 tablet2017-10-020000-00-00NoNoCurrent
67046-229-216704602292121 TABLET in 1 BLISTER PACK (67046-229-21) 21 tablet2017-10-020000-00-00NoNoCurrent
67046-229-286704602292828 TABLET in 1 BLISTER PACK (67046-229-28) 28 tablet2017-10-020000-00-00NoNoCurrent
67046-229-306704602293030 TABLET in 1 BLISTER PACK (67046-229-30) 30 tablet2017-10-020000-00-00NoNoCurrent
67046-229-606704602296060 TABLET in 1 BLISTER PACK (67046-229-60) 60 tablet2017-10-020000-00-00NoNoCurrent