Naloxone Hydrochloride
- Product NDC
- 70069-071
- 11-digit product format
- 700690071
- Labeler code
- 70069
- Product ID
- 70069-071_c30c2699-564b-4c18-89ec-36dfd7df3bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA207633
- Marketing category
- ANDA
- Marketing start
- 2017-08-08
- 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 |
|---|
| 70069-071-01 | Naloxone Hydrochloride | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 10 |
| 70069-071-10 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-071 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20231220_dfa48492-d83b-48cc-9ad1-bdc0c2ac9931.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 |
|---|
| 70069-071-01 | 70069007101 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 70069-071-10 | 70069007110 | 10 VIAL in 1 CARTON (70069-071-10) / 1 mL in 1 VIAL (70069-071-01) | 10 vial | 2017-08-08 | 0000-00-00 | No | No | Current |