Oxcarbazepine
- Product NDC
- 70518-3921
- Requested package NDC
- 70518-3921-0
- 11-digit product format
- 705183921
- Labeler code
- 70518
- Product ID
- 70518-3921_3646eab6-6f97-cf2b-e063-6294a90a1b93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA215939
- Marketing category
- ANDA
- Marketing start
- 2023-11-22
- Substance
- OXCARBAZEPINE
- Active strength
- 300 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215939-001 | OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | |
| A215939-002 | OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | |
| A215939-003 | OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215939-001 | AB |
| A215939-002 | AB |
| A215939-003 | 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 | 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 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2022-01-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2022-01-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A215939-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2022-01-11 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215939-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215939-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215939-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215939-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215939-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215939-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215939-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215939-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215939-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215939-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215939-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A215939-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A215939-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A215939-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A215939-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A215939-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxcarbazepine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXCARBAZEPINE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VZI5B1W380 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312137 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0abe9478-4084-286d-e063-6294a90a9ba7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ca2a6da1-5711-44d0-9e79-c84d4265f98b | Product name | 3 | 20250724 |
| 536d5b6b-66f1-478b-2670-88fd15947e3b | Product name | 7 | 20250218 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-3921-0 | Oxcarbazepine | 100 in 1 BOX | TABLET, FILM COATED | 100 | 4 | |
| 70518-3921-1 | Oxcarbazepine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-3921 | OXCARBAZEPINE TABLET, FILM COATED [REMEDYREPACK INC.] | 3 | Current NDC, 2 package rows | 20240723_0abe9478-4084-286d-e063-6294a90a9ba7.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Oxcarbazepine | OXCARBAZEPINE | Cardinal Health 107, LLC | 3e0f8d9f-7659-4524-8f93-6200314356c8 | 2026-07-21 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | American Health Packaging | c0f9df3f-280e-4394-8d7e-ad04803b2635 | 2026-07-02 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | c7718f8b-63e2-40b9-b519-e687cfc2cacf | 2026-06-11 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 188a48ad-c412-416a-b15b-de5f232740a2 | 2026-06-11 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | REMEDYREPACK INC. | 0abe9478-4084-286d-e063-6294a90a9ba7 | 2026-06-10 | Warnings, Adverse reactions | 215939 ANDA215939 70518-3921-0 70518-3921 70518392100 |
| Oxcarbazepine | OXCARBAZEPINE | ASCLEMED USA INC. | c42b2cb2-8b45-488b-bf63-81909a1f06cb | 2026-05-19 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | Coupler LLC | 512ab25c-ea79-1e59-e063-6294a90ae9a0 | 2026-05-06 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | NCS HealthCare of KY, LLC dba Vangard Labs | 3fb47782-3dfc-458c-92a6-493de1207c0e | 2026-04-02 | Warnings, Adverse reactions | 215939 ANDA215939 |
| OXCARBAZEPINE | OXCARBAZEPINE | NorthStar RxLLC | 20d826cd-fa4a-4570-9e10-9d7d10fb725b | 2026-03-17 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | Camber Pharmaceuticals, Inc. | fe49a773-562c-4da6-96b7-bba52f4d61e2 | 2026-01-30 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | Proficient Rx LP | 433d9d03-a36e-42c6-8e4d-f333ed60e45a | 2025-03-01 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | Bryant Ranch Prepack | 23137a89-cbd0-4a5f-8220-f26b7ba54330 | 2025-01-21 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | AvPAK | fd8da0e9-d69b-7587-e053-6294a90a33c0 | 2025-01-09 | Warnings, Adverse reactions | 215939 ANDA215939 |
| Oxcarbazepine | OXCARBAZEPINE | XLCare Pharmaceuticals Inc. | 9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93 | 2024-07-16 | Warnings, Adverse reactions | 215939 ANDA215939 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312137 | OXcarbazepine 300 MG Oral Tablet | PSN | 0abe9478-4084-286d-e063-6294a90a9ba7 | 4 |
| 312137 | oxcarbazepine 300 MG Oral Tablet | SCD | 0abe9478-4084-286d-e063-6294a90a9ba7 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-3921-0 | 70518392100 | 100 POUCH in 1 BOX (70518-3921-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1) | 100 pouch | 2023-11-22 | No | No | Current |