NALOXONE HYDROCHLORIDE
- Product NDC
- 51662-1586
- 11-digit product format
- 516621586
- Labeler code
- 51662
- Product ID
- 51662-1586_0ffa7c10-a9fe-7701-e063-6394a90a06cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA213279
- Marketing category
- ANDA
- Marketing start
- 2022-08-16
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1586-1 | NALOXONE HYDROCHLORIDE | 2 mL in 1 SYRINGE | INJECTION, SOLUTION | 2 | | 2 |
| 51662-1586-1 | NALOXONE HYDROCHLORIDE | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1586-2 | NALOXONE HYDROCHLORIDE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1586-2 | NALOXONE HYDROCHLORIDE | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1586-3 | NALOXONE HYDROCHLORIDE | 10 in 1 CASE | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1586 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, Legacy NDC, 5 package rows | 20240129_e65e03c1-9a66-b30b-e053-2995a90aeb73.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 |
|---|
| 51662-1586-1 | 51662158601 | 1 SYRINGE in 1 BOX (51662-1586-1) / 2 mL in 1 SYRINGE | 1 syringe | 2022-08-16 | 0000-00-00 | No | No | Current |
| 51662-1586-2 | 51662158602 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1586-3 | 51662158603 | 10 POUCH in 1 CASE (51662-1586-3) / 1 BOX in 1 POUCH (51662-1586-2) / 1 SYRINGE in 1 BOX / 2 mL in 1 SYRINGE | 10 pouch | 2022-08-16 | 0000-00-00 | No | No | Current |