Naloxone Hydrochloride
- Product NDC
- 67457-292
- 11-digit product format
- 674570292
- Labeler code
- 67457
- Product ID
- 67457-292_292c264d-927b-43a6-b9eb-00154f5d13de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA204997
- Marketing category
- ANDA
- Marketing start
- 2014-03-06
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 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 | .4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1659929 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-292-00 | Naloxone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 10 |
| 67457-292-02 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-292 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20210427_f0932877-1f3b-4d5e-82d2-dd6c53db4730.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-292-00 | 67457029200 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 67457-292-02 | 67457029202 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-292-02) / 1 mL in 1 VIAL, SINGLE-DOSE (67457-292-00) | | 2014-03-06 | 0000-00-00 | No | No | Current |