Home NDC 63629-3816 OXCARBAZEPINE
Product NDC 63629-3816
11-digit product format 636293816
Labeler code 63629
Product ID 63629-3816_e1e371c0-49d4-401e-8e7c-b953f579480e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXCARBAZEPINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078069
Marketing category ANDA
Marketing start 2008-01-11
Substance OXCARBAZEPINE
Active strength 150 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 63629-3816-2 excluded package package 63629-3816-1 excluded package package 63629-3816-3
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 A078069-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 A078069-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 A078069-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 132 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 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078069-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2008-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078069-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2008-01-11 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXCARBAZEPINE 150 mg/1
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 312136 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-3816-1 OXCARBAZEPINE 30 in 1 BOTTLE TABLET, FILM COATED 30 1007 63629-3816-2 OXCARBAZEPINE 60 in 1 BOTTLE TABLET, FILM COATED 60 1007 63629-3816-3 OXCARBAZEPINE 90 in 1 BOTTLE TABLET, FILM COATED 90 1007
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-3816 OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1007 Current NDC, Legacy NDC, 3 package rows 20240511_78f196d4-110e-45b1-813a-725f52c1a4eb.zip
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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-3816-1 63629381601 30 TABLET, FILM COATED in 1 BOTTLE (63629-3816-1) 2011-07-28 0000-00-00 No No Current 63629-3816-2 63629381602 60 TABLET, FILM COATED in 1 BOTTLE (63629-3816-2) 2008-10-14 0000-00-00 No No Current 63629-3816-3 63629381603 90 TABLET, FILM COATED in 1 BOTTLE (63629-3816-3) 2012-08-06 0000-00-00 No No Current