Naloxone Hydrochloride
- Product NDC
- 70385-2033
- 11-digit product format
- 703852033
- Labeler code
- 70385
- Product ID
- 70385-2033_48355744-9af7-05f7-e063-6294a90ae4a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sina Health Inc
- 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 |
|---|
| 70385-2033-1 | Naloxone Hydrochloride | 1 in 1 PACKAGE | INJECTION, SOLUTION | 1 | | 11 |
| 70385-2033-1 | Naloxone Hydrochloride | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70385-2033 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [SINA HEALTH INC] | 10 | Current NDC, 2 package rows | 20241207_2879294f-9af9-459e-e063-6394a90a0820.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70385-2033-1 | 70385203301 | 1 VIAL in 1 PACKAGE (70385-2033-1) / 1 mL in 1 VIAL | 1 vial | 2017-08-08 | No | No | Historical |