OXCARBAZEPINE
- Product NDC
- 70377-117
- 11-digit product format
- 703770117
- Labeler code
- 70377
- Product ID
- 70377-117_f99a88aa-8790-c34c-72d2-aa7a7dec80af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OXCARBAZEPINE
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Biocon Pharma Inc.
- Application
- ANDA218278
- Marketing category
- ANDA
- Marketing start
- 2024-05-31
- Substance
- OXCARBAZEPINE
- Active strength
- 60 mg/mL
- 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 | 60 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VZI5B1W380 |
| Rxcui | 283536 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70377-117-11 | OXCARBAZEPINE | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
| 70377-117-11 | OXCARBAZEPINE | 250 mL in 1 BOTTLE | SUSPENSION | 250 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70377-117 | OXCARBAZEPINE SUSPENSION [BIOCON PHARMA INC.] | 1 | Current NDC, 2 package rows | 20240531_62dfed1d-4c5b-446d-97b3-bad9c33959ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70377-117-11 | 70377011711 | 1 BOTTLE in 1 CARTON (70377-117-11) / 250 mL in 1 BOTTLE | 1 bottle | 2024-05-31 | No | No | Current |