gabapentin

Product NDC
62756-202
11-digit product format
627560202
Labeler code
62756
Product ID
62756-202_ca2658ac-c659-4217-8625-a1043d211cd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077525
Marketing category
ANDA
Marketing start
2022-09-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077525-001GABAPENTINGABAPENTIN600MGTABLET / ORAL2006-08-24
A077525-002GABAPENTINGABAPENTIN800MGTABLET / ORAL2006-08-24

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-2484e616aacf4f…
2026-09-14 22:38:342026-08A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-2484e616aacf4f…
2026-08-18 06:07:402026-07A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-24caaa826d4ba7…
2026-08-18 06:07:402026-07A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077525-001GABAPENTIN600MGTABLET / ORAL2006-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077525-002GABAPENTIN800MGTABLET / ORAL2006-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077525-001GABAPENTIN600MGTABLET / ORALAB12006-08-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077525-002GABAPENTIN800MGTABLET / ORALAB12006-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077525-001GABAPENTIN600MGTABLET / ORALAB2006-08-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077525-002GABAPENTIN800MGTABLET / ORALAB2006-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077525-001GABAPENTIN600MGTABLET / ORALAB2006-08-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077525-002GABAPENTIN800MGTABLET / ORALAB2006-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077525-001GABAPENTIN600MGTABLET / ORALAB2006-08-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077525-002GABAPENTIN800MGTABLET / ORALAB2006-08-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077525-001GABAPENTIN600MGTABLET / ORALAB2006-08-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077525-002GABAPENTIN800MGTABLET / ORALAB2006-08-2474a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077525-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077525-002AB115bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A077525-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077525-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077525-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077525-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077525-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077525-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077525-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077525-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077525-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077525-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077525-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077525-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077525-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077525-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077525-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077525-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077525-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077525-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077525-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077525-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077525-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077525-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077525-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077525-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077525-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A077525-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077525-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A077525-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077525-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A077525-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077525-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077525-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077525-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077525-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077525-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077525-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077525-001AB116a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077525-002AB116a51e52b5d6a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
gabapentin
Listing expiration
2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9a05f0c-b5f0-422c-9d67-6d0efc921a74Available 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-202-01EA - Each62756-202e0c0c144-f091-4221-8eb1-4ebf55717ca912012-07-24
62756-202-03EA - Each62756-2027edf1540-38ed-496c-a1c2-10543e1d9b7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET, FILM COATED [UNIT DOSE SERVICES]6
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-202GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]26Current NDC, Legacy NDC20250529_c9a05f0c-b5f0-422c-9d67-6d0efc921a74.zip
62756-202GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4Current NDC, Legacy NDC20141013_1dc96b52-7d43-4274-922f-3a070a165086.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINSun Pharmaceutical Industries, Inc.c9a05f0c-b5f0-422c-9d67-6d0efc921a742026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077525
application number: ANDA077525
ndc (product): 62756-202
gabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC7790d906-af26-4e60-bc6f-e906ec03cc242022-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077525
application number: ANDA077525

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNd8f08084-ef02-4819-9842-72792023297210
310433gabapentin 600 MG Oral TabletSCDd8f08084-ef02-4819-9842-72792023297210
310433gabapentin 600 MG Oral TabletPSN7790d906-af26-4e60-bc6f-e906ec03cc242
310433gabapentin 600 MG Oral TabletSCD7790d906-af26-4e60-bc6f-e906ec03cc242
310433gabapentin 600 MG Oral TabletPSN2fe659eb-a8b4-491b-9195-fe979d7f03731
310434gabapentin 800 MG Oral TabletPSN2fe659eb-a8b4-491b-9195-fe979d7f03731
310433gabapentin 600 MG Oral TabletSCD2fe659eb-a8b4-491b-9195-fe979d7f03731
310434gabapentin 800 MG Oral TabletSCD2fe659eb-a8b4-491b-9195-fe979d7f03731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62756-202-0162756020201100 TABLET, FILM COATED in 1 BOTTLE (62756-202-01) 2022-09-010000-00-00NoNoCurrent
62756-202-0262756020202100 TABLET, FILM COATED in 1 BOTTLE (62756-202-02) 2006-08-240000-00-00NoNoCurrent
62756-202-0362756020203500 TABLET, FILM COATED in 1 BOTTLE (62756-202-03) 2022-09-010000-00-00NoNoCurrent
62756-202-046275602020450 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (62756-202-04) 2006-08-240000-00-00NoNoCurrent