NALMEFENE HYDROCHLORIDE
- Product NDC
- 59011-960
- 11-digit product format
- 590110960
- Labeler code
- 59011
- Product ID
- 59011-960_5c39d4d2-5cb7-4840-b695-6b162e575301
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALMEFENE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Knoa Pharma LLC
- Application
- ANDA212955
- Marketing category
- ANDA
- Marketing start
- 2022-02-08
- Substance
- NALMEFENE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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
- NALMEFENE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALMEFENE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K7K69QC05X |
| Rxcui | 2592953 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59011-960-10 | NALMEFENE HYDROCHLORIDE | 2 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2 | | 7 |
| 59011-960-10 | NALMEFENE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59011-960 | NALMEFENE HYDROCHLORIDE INJECTION, SOLUTION [PURDUE PHARMA L.P.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241225_3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59011-960-10 | 59011096010 | 10 VIAL, GLASS in 1 CARTON (59011-960-10) / 2 mL in 1 VIAL, GLASS | 2022-02-08 | 0000-00-00 | No | No | Current |