naloxone hydrochloride
- Product NDC
- 70756-850
- 11-digit product format
- 707560850
- Labeler code
- 70756
- Product ID
- 70756-850_2a618429-eb01-4c0b-8291-dca1ebc037c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA218404
- Marketing category
- ANDA
- Marketing start
- 2026-02-19
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 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
- naloxone hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 70756-850-10 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 70756-850-10 | naloxone hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
| 70756-850-25 | naloxone hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 1 |
| 70756-850-25 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 70756-850-82 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 70756-850-82 | naloxone hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70756-850-10 | 70756085010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70756-850-10) / 1 mL in 1 VIAL, SINGLE-DOSE | 2026-02-19 | No | No | Current |
| 70756-850-25 | 70756085025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70756-850-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2026-02-19 | No | No | Current |
| 70756-850-82 | 70756085082 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70756-850-82) / 1 mL in 1 VIAL, SINGLE-DOSE | 2026-02-19 | No | No | Current |