FDA.reportPublic FDA data

Gabapentin

Product NDC
59115-075
11-digit product format
591150075
Labeler code
59115
Product ID
59115-075_644343c6-5cd6-435f-a260-0d62901b3b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceutical
Application
ANDA078150
Marketing category
ANDA
Marketing start
2007-07-09
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

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
A078150-001GABAPENTINGABAPENTIN100MGCAPSULE / ORAL2007-09-25
A078150-002GABAPENTINGABAPENTIN300MGCAPSULE / ORAL2007-09-25
A078150-003GABAPENTINGABAPENTIN400MGCAPSULE / ORAL2007-09-25

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-002GABAPENTIN300MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078150-003GABAPENTIN400MGCAPSULE / ORAL2007-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078150-001GABAPENTIN100MGCAPSULE / ORAL2007-09-25301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [HIKMA PHARMACEUTICAL]10