Home NDC 59651-787-01 Oxcarbazepine
Product NDC 59651-787
Requested package NDC 59651-787-01
11-digit product format 596510787
Labeler code 59651
Product ID 59651-787_6e11231c-bc13-42e1-ac5e-097709d8b35d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA219241
Marketing category ANDA
Marketing start 2026-10-16
Substance OXCARBAZEPINE
Active strength 600 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219241-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 A219241-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 A219241-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30
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.
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 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219241-001 OXCARBAZEPINE 150MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219241-002 OXCARBAZEPINE 300MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219241-003 OXCARBAZEPINE 600MG TABLET, EXTENDED RELEASE / ORAL 2025-04-30 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Oxcarbazepine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 600 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-787-01 59651078701 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-787-01) 2026-10-16 No No Current