FDA.reportPublic FDA data

Gabapentin

Product NDC
68382-204
11-digit product format
683820204
Labeler code
68382
Product ID
68382-204_e85a763f-472b-492b-bf25-a30251b9b50b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078926
Marketing category
ANDA
Marketing start
2012-10-16
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-204-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10017
68382-204-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50017
68382-204-10Gabapentin1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-204-01EA - Each68382-204e5c8bbe7-966d-4389-988a-becdbd1ddb5712013-02-13
68382-204-05EA - Each68382-2045a02ba67-26b9-4983-9115-f019669ee03d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-204GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 3 package rows20250509_310ce005-5a24-489a-b23c-d42ab6a3bfed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN81774da8-cb1d-4c7d-8550-35396850d5ff21
310433gabapentin 600 MG Oral TabletSCD81774da8-cb1d-4c7d-8550-35396850d5ff21
310433gabapentin 600 MG Oral TabletPSN310ce005-5a24-489a-b23c-d42ab6a3bfed17
310434gabapentin 800 MG Oral TabletPSN310ce005-5a24-489a-b23c-d42ab6a3bfed17
310433gabapentin 600 MG Oral TabletSCD310ce005-5a24-489a-b23c-d42ab6a3bfed17
310434gabapentin 800 MG Oral TabletSCD310ce005-5a24-489a-b23c-d42ab6a3bfed17
310433gabapentin 600 MG Oral TabletPSN765c7ce0-bbf5-4265-8ff0-1ba092c698656
310434gabapentin 800 MG Oral TabletPSN765c7ce0-bbf5-4265-8ff0-1ba092c698656
310433gabapentin 600 MG Oral TabletSCD765c7ce0-bbf5-4265-8ff0-1ba092c698656
310434gabapentin 800 MG Oral TabletSCD765c7ce0-bbf5-4265-8ff0-1ba092c698656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-204-0168382020401100 TABLET, FILM COATED in 1 BOTTLE (68382-204-01) 2012-10-160000-00-00NoNoCurrent
68382-204-0568382020405500 TABLET, FILM COATED in 1 BOTTLE (68382-204-05) 2012-10-160000-00-00NoNoCurrent
68382-204-10683820204101000 TABLET, FILM COATED in 1 BOTTLE (68382-204-10) 2012-10-160000-00-00NoNoCurrent