Home NDC 62756-185 Oxcarbazepine
Product NDC 62756-185
11-digit product format 627560185
Labeler code 62756
Product ID 62756-185_56aeed00-02fa-483d-b4be-45362e10f5ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxcarbazepine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA077794
Marketing category ANDA
Marketing start 2007-10-09
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A077794-001 OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 A077794-002 OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 A077794-003 OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-002 OXCARBAZEPINE 300MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077794-003 OXCARBAZEPINE 600MG TABLET / ORAL AB 2007-10-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077794-001 OXCARBAZEPINE 150MG TABLET / ORAL AB 2007-10-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312136 Internal RxNorm lookup 312137 Internal RxNorm lookup 312138 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 62756-185-08 Oxcarbazepine 100 in 1 BOTTLE TABLET, FILM COATED 100 21 62756-185-13 Oxcarbazepine 500 in 1 BOTTLE TABLET, FILM COATED 500 21 62756-185-18 Oxcarbazepine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 21 62756-185-83 Oxcarbazepine 30 in 1 BOTTLE TABLET, FILM COATED 30 21 62756-185-88 Oxcarbazepine 100 in 1 BOTTLE TABLET, FILM COATED 100 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 14 OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ] 6 OXCARBAZEPINE ACTIVE INGREDIENT VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 OXCARBAZEPINE ACTIVE MOIETY VZI5B1W380 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OXCARBAZEPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-185 OXCARBAZEPINE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 19 Current NDC, Legacy NDC, 5 package rows 20241112_7ecd5eef-46f4-407f-9b63-ba65adb3eced.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 1 of 1 · 2 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 62756-185-08 62756018508 100 TABLET, FILM COATED in 1 BOTTLE (62756-185-08) 2007-10-09 0000-00-00 No No Current 62756-185-13 62756018513 500 TABLET, FILM COATED in 1 BOTTLE (62756-185-13) 2007-10-09 0000-00-00 No No Current 62756-185-18 62756018518 1000 TABLET, FILM COATED in 1 BOTTLE (62756-185-18) 2007-10-09 0000-00-00 No No Current 62756-185-83 62756018583 30 TABLET, FILM COATED in 1 BOTTLE (62756-185-83) 2007-10-09 0000-00-00 No No Current 62756-185-88 62756018588 100 TABLET, FILM COATED in 1 BOTTLE (62756-185-88) 2007-10-09 0000-00-00 No No Current