Home NDC 60505-2550 Gabapentin
Product NDC 60505-2550
11-digit product format 605052550
Labeler code 60505
Product ID 60505-2550_7ce1e8e4-911a-c769-89bb-bb4ab04904b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA077894
Marketing category ANDA
Marketing start 2006-10-10
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 2019-12-31
Current FDA listing Historical FDA.report record
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 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077894-001 GABAPENTIN GABAPENTIN 100MG TABLET / ORAL 2006-10-10 A077894-002 GABAPENTIN GABAPENTIN 300MG TABLET / ORAL 2006-10-10 A077894-003 GABAPENTIN GABAPENTIN 400MG TABLET / ORAL 2006-10-10
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077894-001 GABAPENTIN 100MG TABLET / ORAL 2006-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077894-002 GABAPENTIN 300MG TABLET / ORAL 2006-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077894-003 GABAPENTIN 400MG TABLET / ORAL 2006-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077894-001 GABAPENTIN 100MG TABLET / ORAL 2006-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077894-002 GABAPENTIN 300MG TABLET / ORAL 2006-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077894-003 GABAPENTIN 400MG TABLET / ORAL 2006-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077894-001 GABAPENTIN 100MG TABLET / ORAL 2006-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077894-002 GABAPENTIN 300MG TABLET / ORAL 2006-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077894-003 GABAPENTIN 400MG TABLET / ORAL 2006-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077894-001 GABAPENTIN 100MG TABLET / ORAL 2006-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077894-002 GABAPENTIN 300MG TABLET / ORAL 2006-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077894-003 GABAPENTIN 400MG TABLET / ORAL 2006-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077894-001 GABAPENTIN 100MG TABLET / ORAL 2006-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077894-002 GABAPENTIN 300MG TABLET / ORAL 2006-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077894-003 GABAPENTIN 400MG TABLET / ORAL 2006-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077894-002 GABAPENTIN 300MG TABLET / ORAL AB1 2006-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077894-003 GABAPENTIN 400MG TABLET / ORAL AB1 2006-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077894-001 GABAPENTIN 100MG TABLET / ORAL AB1 2006-10-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [APOTEX CORP.] 3