Gabapentin

Product NDC
63304-629
11-digit product format
633040629
Labeler code
63304
Product ID
63304-629_3ac31363-4eb4-4333-ba7f-fc2db7b42439
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076606
Marketing category
ANDA
Marketing start
2005-11-02
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-629IInactivated by FDA2026-10-16
excluded packagepackage63304-62963304-629-01IInactivated by FDA2026-10-16
excluded packagepackage63304-62963304-629-05IInactivated by FDA2026-10-16
excluded packagepackage63304-62963304-629-30IInactivated by FDA2026-10-16
excluded packagepackage63304-62963304-629-51IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-629-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-629-51d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-629-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-629-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-629-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-629-51f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-629-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-629-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-629-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-629-512ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-629-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-629-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-629-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-629-51a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-629-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-629-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-629-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-629-51cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-629-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-629-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-629-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-629-51cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-629-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-629-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-629-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-629-51302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-629-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-629-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-629-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-629-51ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-629-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-629-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-629-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-629-510efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-629-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-629-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-629-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-629-51ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-629-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-629-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-629-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-629-51367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-629-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-629-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-629-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-629-51557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-629-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-629-01557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076606-001GABAPENTINGABAPENTIN100MGCAPSULE / ORAL2005-10-07
A076606-002GABAPENTINGABAPENTIN300MGCAPSULE / ORAL2005-10-07
A076606-003GABAPENTINGABAPENTIN400MGCAPSULE / ORAL2005-10-07

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07c2088c7a36db…
2026-10-15 13:18:302026-09A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07c2088c7a36db…
2026-10-15 13:18:302026-09A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07c2088c7a36db…
2026-09-14 22:38:342026-08A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-0784e616aacf4f…
2026-09-14 22:38:342026-08A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-0784e616aacf4f…
2026-09-14 22:38:342026-08A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-0784e616aacf4f…
2026-08-18 06:07:402026-07A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07caaa826d4ba7…
2026-08-18 06:07:402026-07A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A076606-002GABAPENTIN300MGCAPSULE / ORAL2005-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A076606-003GABAPENTIN400MGCAPSULE / ORAL2005-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076606-001GABAPENTIN100MGCAPSULE / ORAL2005-10-0779d66fd596c7…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-629-01Gabapentin100 in 1 BOTTLECAPSULE1005
63304-629-05Gabapentin500 in 1 BOTTLECAPSULE5005
63304-629-30Gabapentin30 in 1 BOTTLECAPSULE305
63304-629-51Gabapentin1 in 1 BLISTER PACKCAPSULE15
63304-629-51Gabapentin50 in 1 CARTONCAPSULE505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-629-01EA - Each63304-6299908b81c-41a1-4cdc-8039-e10e901b5bd512015-10-02
63304-629-05EA - Each63304-629865525d3-9559-40e1-a106-bf15f6c126bf12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-629GABAPENTIN (GABAPENTIN ) CAPSULE [RANBAXY PHARMACEUTICALS INC.]5Legacy NDC, 5 package rows20140317_0936a88f-b569-49c4-951b-14e8f6273b53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310431gabapentin 300 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310432gabapentin 400 MG Oral CapsulePSN0936a88f-b569-49c4-951b-14e8f6273b535
310430gabapentin 100 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535
310431gabapentin 300 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535
310432gabapentin 400 MG Oral CapsuleSCD0936a88f-b569-49c4-951b-14e8f6273b535

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-629-0163304062901100 in 1 BOTTLEHistorical
63304-629-0563304062905500 in 1 BOTTLEHistorical
63304-629-306330406293030 in 1 BOTTLEHistorical
63304-629-51633040629511 in 1 BLISTER PACKHistorical