cocaine hydrochloride nasal
- Product NDC
- 81665-301
- 11-digit product format
- 816650301
- Labeler code
- 81665
- Product ID
- 81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cocaine hydrochloride nasal
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.
- Application
- NDA209575
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2023-10-15
- 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
- cocaine hydrochloride nasal
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81665-301-02 | cocaine hydrochloride nasal | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 81665-301-02 | cocaine hydrochloride nasal | 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 |
|---|
| 81665-301 | COCAINE HYDROCHLORIDE NASAL SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.] | 1 | Current NDC, 2 package rows | 20231015_4e3b2f6b-1b57-40bc-872b-01c0a3c7986e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81665-301-02 | 81665030102 | 1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS | 2023-10-15 | No | No | Historical |