Naloxone Hydrochloride
- Product NDC
- 50090-6491
- 11-digit product format
- 500906491
- Labeler code
- 50090
- Product ID
- 50090-6491_139efb34-7bd4-46a7-9aeb-20e7b973d7a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- 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 |
|---|
| 50090-6491-0 | Naloxone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 50090-6491-0 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6491 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20230525_3d2dcee4-7510-477b-95a8-9b2afb773984.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6491-0 | 50090649100 | 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-6491-0) / 1 mL in 1 VIAL, SINGLE-DOSE | 2023-05-19 | No | No | Historical |