Home NDC 70377-117 OXCARBAZEPINE
Product NDC 70377-117
11-digit product format 703770117
Labeler code 70377
Product ID 70377-117_3a03d0df-81f9-c49e-c812-a713524a7de0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXCARBAZEPINE
Dosage form SUSPENSION
Route ORAL
Labeler Biocon Pharma Inc.
Application ANDA218278
Marketing category ANDA
Marketing start 2024-05-31
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 45 .
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 A218278-001 OXCARBAZEPINE OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218278-001 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 2026-11-14 07:37:17 2026-10 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218278-001 OXCARBAZEPINE 300MG/5ML SUSPENSION / ORAL AB 2024-03-01 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283536 Internal RxNorm 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 70377-117-11 OXCARBAZEPINE 1 in 1 CARTON SUSPENSION 1 1 70377-117-11 OXCARBAZEPINE 250 mL in 1 BOTTLE SUSPENSION 250 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70377-117 OXCARBAZEPINE SUSPENSION [BIOCON PHARMA INC.] 1 Current NDC, 2 package rows 20240531_62dfed1d-4c5b-446d-97b3-bad9c33959ff.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 70377-117-11 70377011711 1 BOTTLE in 1 CARTON (70377-117-11) / 250 mL in 1 BOTTLE 1 bottle 2024-05-31 No No Current