OXCARBAZEPINE
- Product NDC
- 51991-293
- 11-digit product format
- 519910293
- Labeler code
- 51991
- Product ID
- 51991-293_7b71db65-df59-4739-9e8f-77aea32f80b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA078069
- Marketing category
- ANDA
- Marketing start
- 2008-01-11
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OXCARBAZEPINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 312136, 312137, 312138 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51991-293-01 | OXCARBAZEPINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 22 |
| 51991-293-05 | OXCARBAZEPINE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 12 | |
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51991-293 | OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240327_682a1210-b26e-426e-8ffe-d25d91bdd608.zip |
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 |
|---|
| 51991-293-01 | 51991029301 | 100 TABLET, FILM COATED in 1 BOTTLE (51991-293-01) | 2008-01-11 | 0000-00-00 | No | No | Current |
| 51991-293-05 | 51991029305 | 500 TABLET, FILM COATED in 1 BOTTLE (51991-293-05) | 2008-01-11 | 0000-00-00 | No | No | Current |