Naloxone Hydrochloride
- Product NDC
- 76045-112
- 11-digit product format
- 760450112
- Labeler code
- 76045
- Product ID
- 76045-112_6503f42d-3303-497a-9653-4b6d89bf7833
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA213573
- Marketing category
- ANDA
- Marketing start
- 2024-04-02
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191250, 2679504 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-112-01 | Naloxone Hydrochloride | 2 mL in 1 SYRINGE | INJECTION, SOLUTION | 2 | | 5 |
| 76045-112-20 | Naloxone Hydrochloride | 24 in 1 CASE | INJECTION, SOLUTION | 24 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-112 | NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 4 | Current NDC, 2 package rows | 20240802_201fdedf-1736-4e52-9d7d-de14292547fd.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 |
|---|
| 76045-112-01 | 76045011201 | 2 mL in 1 SYRINGE | 2 ml | | | | Historical |
| 76045-112-20 | 76045011220 | 24 SYRINGE in 1 CASE (76045-112-20) / 2 mL in 1 SYRINGE (76045-112-01) | 24 syringe | 2024-04-02 | No | No | Current |