Home NDC 67877-532 Oxcarbazepine
Product NDC 67877-532
11-digit product format 678770532
Labeler code 67877
Product ID 67877-532_80679158-b933-4c1b-892f-35ed487e058b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form SUSPENSION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA213183
Marketing category ANDA
Marketing start 2020-01-01
Substance OXCARBAZEPINE
Active strength 60 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213183-001 OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213183-001 AB
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 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 c2088c7a36db…2026-09-14 22:38:34 2026-08 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213183-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2023-03-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZI5B1W380 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67877-532-58 Oxcarbazepine 250 mL in 1 BOTTLE SUSPENSION 250 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-532 OXCARBAZEPINE SUSPENSION [ASCEND LABORATORIES, LLC] 5 Current NDC, 1 package rows 20250228_3f36f519-c30c-4929-afa0-9844dc531e3f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 67877-532-58 67877053258 250 mL in 1 BOTTLE (67877-532-58) 250 ml 2020-01-01 No No Current