naloxone hydrochloride
- Product NDC
- 70756-658
- 11-digit product format
- 707560658
- Labeler code
- 70756
- Product ID
- 70756-658_bc5568c5-97d3-49b1-94c7-f9f3c6c9d409
- 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
- 2024-02-29
- 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 |
|---|
| 70756-658-10 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
| 70756-658-10 | naloxone hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 70756-658-25 | naloxone hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 2 |
| 70756-658-25 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
| 70756-658-82 | naloxone hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
| 70756-658-82 | naloxone hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-658 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [LIFESTAR PHARMA LLC] | 2 | Current NDC, 6 package rows | 20240305_ef647e2a-84e7-4e3e-942a-b6fc250141b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70756-658-10 | 70756065810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-10) / 1 mL in 1 VIAL, SINGLE-DOSE | 2024-02-29 | No | No | Current |
| 70756-658-25 | 70756065825 | 25 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2024-02-29 | No | No | Current |
| 70756-658-82 | 70756065882 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70756-658-82) / 1 mL in 1 VIAL, SINGLE-DOSE | 2024-02-29 | No | No | Current |