Gabapentin

Product NDC
67046-413
11-digit product format
670460413
Labeler code
67046
Product ID
67046-413_a8537d20-3dcc-239a-e053-2995a90a1927
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA203244
Marketing category
ANDA
Marketing start
2020-06-15
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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-413-30Gabapentin30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-413GABAPENTIN TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20200619_a8539169-25fc-79e7-e053-2995a90a6925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310433gabapentin 600 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-413-306704604133030 TABLET, FILM COATED in 1 BLISTER PACK (67046-413-30) 2020-06-150000-00-00NoNoCurrent