Oxcarbazepine
- Product NDC
- 21695-863
- 11-digit product format
- 216950863
- Labeler code
- 21695
- Product ID
- 21695-863_e8a485af-a78b-49a0-9bf4-75e1cd5bb740
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA077802
- Marketing category
- ANDA
- Marketing start
- 2007-10-09
- Marketing end
- 0000-00-00
- Substance
- OXCARBAZEPINE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-863-60 | Oxcarbazepine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| 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 |
|---|
| 21695-863 | OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20111021_e8a485af-a78b-49a0-9bf4-75e1cd5bb740.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-863-60 | 21695086360 | 60 in 1 BOTTLE | Historical |