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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078926-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12011-02-11
A078926-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12011-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A078926-001AB1
A078926-002AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11caaa826d4ba7…
2026-08-18 06:07:402026-07A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078926-001GABAPENTIN600MGTABLET / ORALAB12011-02-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078926-002GABAPENTIN800MGTABLET / ORALAB12011-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078926-001GABAPENTIN600MGTABLET / ORALAB2011-02-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078926-002GABAPENTIN800MGTABLET / ORALAB2011-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078926-001GABAPENTIN600MGTABLET / ORALAB2011-02-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078926-002GABAPENTIN800MGTABLET / ORALAB2011-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078926-001GABAPENTIN600MGTABLET / ORALAB2011-02-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078926-002GABAPENTIN800MGTABLET / ORALAB2011-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078926-001GABAPENTIN600MGTABLET / ORALAB2011-02-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078926-002GABAPENTIN800MGTABLET / ORALAB2011-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078926-001GABAPENTIN600MGTABLET / ORALAB2011-02-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078926-002GABAPENTIN800MGTABLET / ORALAB2011-02-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078926-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A078926-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078926-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078926-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078926-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078926-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078926-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078926-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078926-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078926-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078926-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078926-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078926-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078926-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078926-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078926-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078926-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078926-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078926-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078926-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078926-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A078926-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078926-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078926-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078926-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078926-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078926-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078926-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078926-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078926-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078926-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078926-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078926-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078926-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078926-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078926-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078926-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078926-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078926-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078926-002AB1bb7c543d1eb4…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup
310434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310ce005-5a24-489a-b23c-d42ab6a3bfedAvailable on FDA.report

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
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCardinal Health 107, LLCeeb19a5a-b31d-4df8-9546-0b2b5eb5db072026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078926
application number: ANDA078926
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.d22ed424-f365-44ca-8ef9-a08255a90ae82026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078926
application number: ANDA078926
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.81774da8-cb1d-4c7d-8550-35396850d5ff2026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078926
application number: ANDA078926
GabapentinGABAPENTINZydus Pharmaceuticals USA Inc.310ce005-5a24-489a-b23c-d42ab6a3bfed2025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078926
application number: ANDA078926
ndc (product): 68382-204
GabapentinGABAPENTINAmerican Health Packaging765c7ce0-bbf5-4265-8ff0-1ba092c698652025-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078926
application number: ANDA078926
GabapentinGABAPENTINZydus Lifesciences Limitedb033c169-4943-4ad9-ace0-7e4a1f0dc1002024-11-30Exact identifier
application applno (ANDA): 078926
application number: ANDA078926

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