FDA.reportPublic FDA data

Gabapentin

Product NDC
68382-205
11-digit product format
683820205
Labeler code
68382
Product ID
68382-205_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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68382-205-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED10017
68382-205-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50017
68382-205-10Gabapentin1000 in 1 BOTTLETABLET, FILM COATED100017
68382-205-30Gabapentin1 in 1 BLISTER PACKTABLET, FILM COATED117
68382-205-77Gabapentin100 in 1 CARTONTABLET, FILM COATED10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-205-01EA - Each68382-205a6131ec4-32a2-4098-b525-3c3a67c6c2a912013-02-13
68382-205-05EA - Each68382-2056b3d1cfc-b1db-4b15-b14f-d30ea1b243cf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]7
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [DIRECT RX]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [DIRECT RX]2
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [DIRECT RX]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [DIRECT RX]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [DIRECT RX]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-205GABAPENTIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 5 package rows20250509_310ce005-5a24-489a-b23c-d42ab6a3bfed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSNd22ed424-f365-44ca-8ef9-a08255a90ae821
310434gabapentin 800 MG Oral TabletSCDd22ed424-f365-44ca-8ef9-a08255a90ae821
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
310434gabapentin 800 MG Oral TabletPSN14460d38-f4cd-43bb-8b1f-1ec299e6d1553
310434gabapentin 800 MG Oral TabletSCD14460d38-f4cd-43bb-8b1f-1ec299e6d1553
310434gabapentin 800 MG Oral TabletPSN5b64e806-596f-4ebf-9dfa-e93ea5470c2f2
310434gabapentin 800 MG Oral TabletSCD5b64e806-596f-4ebf-9dfa-e93ea5470c2f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-205-0168382020501100 TABLET, FILM COATED in 1 BOTTLE (68382-205-01) 2012-10-160000-00-00NoNoCurrent
68382-205-0568382020505500 TABLET, FILM COATED in 1 BOTTLE (68382-205-05) 2012-10-160000-00-00NoNoCurrent
68382-205-10683820205101000 TABLET, FILM COATED in 1 BOTTLE (68382-205-10) 2012-10-160000-00-00NoNoCurrent
68382-205-30683820205301 in 1 BLISTER PACKHistorical
68382-205-7768382020577100 BLISTER PACK in 1 CARTON (68382-205-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-205-30) 100 blister pack2012-10-160000-00-00NoNoCurrent