Oxcarbazepine
- Product NDC
- 68462-138
- 11-digit product format
- 684620138
- Labeler code
- 68462
- Product ID
- 68462-138_80b48b96-6521-491c-831a-2356c22e39f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA077802
- Marketing category
- ANDA
- Marketing start
- 2007-10-09
- 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 |
|---|
| 68462-138-01 | Oxcarbazepine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 18 |
| 68462-138-05 | Oxcarbazepine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 8 | |
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 5 | |
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-138 | OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241107_1c713b59-a628-42e6-b166-ae71c3913284.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 |
|---|
| 68462-138-01 | 68462013801 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-138-01) | 2007-10-09 | 0000-00-00 | No | No | Current |
| 68462-138-05 | 68462013805 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-138-05) | 2007-10-09 | 0000-00-00 | No | No | Current |