Gabapentin

Product NDC
58118-1103
11-digit product format
581181103
Labeler code
58118
Product ID
58118-1103_15c4b320-aeb7-6e3b-e063-6294a90a277b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
58118-1103-8Gabapentin30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1103GABAPENTIN CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]1Current NDC, 1 package rows20240412_dbedccfb-0e27-4119-93b9-241c039e045a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsulePSNdbedccfb-0e27-4119-93b9-241c039e045a1
310430gabapentin 100 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310431gabapentin 300 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1
310432gabapentin 400 MG Oral CapsuleSCDdbedccfb-0e27-4119-93b9-241c039e045a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58118-1103-85811811030830 CAPSULE in 1 BLISTER PACK (58118-1103-8) 30 capsule2024-04-10NoNoHistorical