Home NDC 0093-4444 Gabapentin
Product NDC 0093-4444
11-digit product format 000934444
Labeler code 0093
Product ID 0093-4444_76e073b2-ef68-479a-938e-417338fc4105
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076017
Marketing category ANDA
Marketing start 2008-08-01
Marketing end 2019-05-31
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 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076017-001 GABAPENTIN GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 A076017-002 GABAPENTIN GABAPENTIN 300MG TABLET / ORAL 2004-04-28 A076017-003 GABAPENTIN GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 A076017-004 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2005-04-29 A076017-005 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2005-04-29
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 6 · 220 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 2026-10-15 13:18:30 2026-09 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076017-002 GABAPENTIN 300MG TABLET / ORAL 2004-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076017-002 GABAPENTIN 300MG TABLET / ORAL AB1 2004-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076017-001 GABAPENTIN 100MG TABLET / ORAL AB1 2004-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076017-002 GABAPENTIN 300MG TABLET / ORAL AB1 2004-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076017-003 GABAPENTIN 400MG TABLET / ORAL AB1 2004-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076017-004 GABAPENTIN 600MG TABLET / ORAL 2005-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076017-005 GABAPENTIN 800MG TABLET / ORAL 2005-04-29 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 127 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed RxNorm Mappings#