Home NDC 60505-2552 Gabapentin
Product NDC 60505-2552
11-digit product format 605052552
Labeler code 60505
Product ID 60505-2552_495d183d-f43e-cd94-750f-632891121be7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA077661
Marketing category ANDA
Marketing start 2006-09-15
Marketing end 2021-03-31
Substance GABAPENTIN
Active strength 800 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 0000-00-00
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 2 · 120 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077661-004 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 A077661-005 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 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 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB1 2006-09-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB1 2006-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077661-004 GABAPENTIN 600MG TABLET / ORAL AB 2006-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077661-005 GABAPENTIN 800MG TABLET / ORAL AB 2006-09-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-2552-1 60505255201 100 TABLET, FILM COATED in 1 BOTTLE (60505-2552-1) 2006-09-15 2021-03-31 No No Current 60505-2552-5 60505255205 500 TABLET, FILM COATED in 1 BOTTLE (60505-2552-5) 2006-09-15 2021-03-31 No No Current