Oxcarbazepine
- Product NDC
- 90096-173
- Requested package NDC
- 90096-173-01
- 11-digit product format
- 900960173
- Labeler code
- 90096
- Product ID
- 90096-173_372b49f4-e5ec-491f-9312-38dc0c5b63c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zameer Pharmaceuticals LLC
- Application
- ANDA218341
- Marketing category
- ANDA
- Marketing start
- 2026-07-06
- 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
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218341-001 | OXCARBAZEPINE | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2026-04-29 | |
| A218341-002 | OXCARBAZEPINE | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2026-04-29 | |
| A218341-003 | OXCARBAZEPINE | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2026-04-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218341-001 | AB |
| A218341-002 | AB |
| A218341-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218341-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2026-04-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218341-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2026-04-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218341-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2026-04-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218341-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2026-04-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218341-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2026-04-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218341-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2026-04-29 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-001 | OXCARBAZEPINE | 150MG | TABLET / ORAL | AB | 2026-04-29 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-002 | OXCARBAZEPINE | 300MG | TABLET / ORAL | AB | 2026-04-29 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-003 | OXCARBAZEPINE | 600MG | TABLET / ORAL | AB | 2026-04-29 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218341-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218341-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218341-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218341-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218341-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218341-003 | AB | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218341-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|
| OXCARBAZEPINE | 600 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VZI5B1W380 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8841174a-9f4b-424f-a50d-01478f2aeb29 | Available on FDA.report |
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 | Zameer Pharmaceuticals LLC | 8841174a-9f4b-424f-a50d-01478f2aeb29 | 2026-08-26 | Warnings, Adverse reactions | 218341 ANDA218341 90096-173-01 90096-173 90096017301 |
| Oxcarbazepine | OXCARBAZEPINE | Umedica Laboratories USA Inc. | e46d4654-76bc-4c33-ac2b-e89ae11b7697 | 2026-05-05 | Warnings, Adverse reactions | 218341 ANDA218341 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 90096-173-01 | 90096017301 | 100 TABLET, FILM COATED in 1 BOTTLE (90096-173-01) | 2026-07-06 | No | No | Current |