Zurnai
- Product NDC
- 59011-962
- 11-digit product format
- 590110962
- Labeler code
- 59011
- Product ID
- 59011-962_34c86c07-3873-4f16-ac8d-8284c68426c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALMEFENE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Knoa Pharma LLC
- Application
- NDA218590
- Marketing category
- NDA
- Marketing start
- 2025-08-07
- Substance
- NALMEFENE HYDROCHLORIDE
- Active strength
- 1.5 mg/.5mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zurnai
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALMEFENE HYDROCHLORIDE | 1.5 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K7K69QC05X |
| Rxcui | 2720806, 2720812 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59011-962-01 | Zurnai | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 7 |
| 59011-962-01 | Zurnai | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.5 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59011-962-01 | 59011096201 | 1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS | 2025-08-07 | No | No | Historical |