Naloxone Hydrochloride
- Product NDC
- 70069-072
- 11-digit product format
- 700690072
- Labeler code
- 70069
- Product ID
- 70069-072_7a544942-0f60-4ed3-91df-049b7f74812e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA207634
- Marketing category
- ANDA
- Marketing start
- 2017-07-26
- 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 | 1191222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-072-01 | Naloxone Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 70069-072-01 | Naloxone Hydrochloride | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 9 |
| 70069-072-10 | Naloxone Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-072 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20231220_b59ee3cc-9604-4abc-81be-897e2f42aa67.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 |
|---|
| 70069-072-01 | 70069007201 | 1 in 1 CARTON | | | | | | Historical |
| 70069-072-10 | 70069007210 | 10 CARTON in 1 BOX (70069-072-10) / 1 VIAL, GLASS in 1 CARTON (70069-072-01) / 10 mL in 1 VIAL, GLASS | 10 carton | 2017-07-26 | 0000-00-00 | No | No | Current |