GABAPENTIN

Product NDC
58118-1167
11-digit product format
581181167
Labeler code
58118
Product ID
58118-1167_15d3ae78-fa44-ff38-e063-6394a90a1430
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-1167-8GABAPENTIN30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1167GABAPENTIN TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]1Current NDC, 1 package rows20240413_934fefae-b895-427c-8798-4c5462b1ecc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN934fefae-b895-427c-8798-4c5462b1ecc21
310434gabapentin 800 MG Oral TabletPSN934fefae-b895-427c-8798-4c5462b1ecc21
310433gabapentin 600 MG Oral TabletSCD934fefae-b895-427c-8798-4c5462b1ecc21
310434gabapentin 800 MG Oral TabletSCD934fefae-b895-427c-8798-4c5462b1ecc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58118-1167-85811811670830 TABLET in 1 BLISTER PACK (58118-1167-8) 30 tablet2024-04-11NoNoHistorical