Trileptal
- Product NDC
- 0078-0457
- 11-digit product format
- 000780457
- Labeler code
- 0078
- Product ID
- 0078-0457_dcd739ce-e938-40e6-8912-ca4f34b49cf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oxcarbazepine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021014
- Marketing category
- NDA
- Marketing start
- 2000-01-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Trileptal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OXCARBAZEPINE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 261356, 261360, 262090, 283536, 312136, 312137, 312138, 351992 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0457-05 | Trileptal | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 39 |
| 0078-0457-35 | Trileptal | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 39 |
| 0078-0457-61 | Trileptal | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 39 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OXCARBAZEPINE | ACTIVE INGREDIENT | VZI5B1W380 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| OXCARBAZEPINE | ACTIVE MOIETY | VZI5B1W380 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| LEMON | INACTIVE INGREDIENT | 24RS0A988O | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| PLUM | INACTIVE INGREDIENT | 67M3EQ6BE1 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 20 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0457 | TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] | 37 | Current NDC, Legacy NDC, 3 package rows | 20250122_4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0457-05 | 00078045705 | 100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05) | | 2000-01-30 | 0000-00-00 | No | No | Current |
| 0078-0457-35 | 00078045735 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0078-0457-35) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0078-0457-61) | 100 blister pack | 2000-01-30 | 0000-00-00 | No | No | Current |
| 0078-0457-61 | 00078045761 | 1 in 1 BLISTER PACK | | | | | | Historical |