Goprelto
- Product NDC
- 70839-359
- 11-digit product format
- 708390359
- Labeler code
- 70839
- Product ID
- 70839-359_0f897764-fe31-090a-e063-6294a90af106
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cocaine hydrochloride
- Dosage form
- SOLUTION
- Route
- NASAL
- Labeler
- LXO US Inc.
- Application
- NDA209963
- Marketing category
- NDA
- Marketing start
- 2024-02-09
- Substance
- COCAINE HYDROCHLORIDE
- Active strength
- 40 mg/mL
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Goprelto
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COCAINE HYDROCHLORIDE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XH8T8T6WZH |
| Rxcui | 1995288, 1995293 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70839-359-04 | Goprelto | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 70839-359-04 | Goprelto | 4 mL in 1 BOTTLE, GLASS | SOLUTION | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70839-359 | GOPRELTO (COCAINE HYDROCHLORIDE) SOLUTION [LXO US INC.] | 1 | Current NDC, 2 package rows | 20241107_0f897764-fe30-090a-e063-6294a90af106.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70839-359-04 | 70839035904 | 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS | 2024-02-09 | No | No | Current |