Naloxone Hydrochloride
- Product NDC
- 0409-1782
- 11-digit product format
- 004091782
- Labeler code
- 0409
- Product ID
- 0409-1782_568bacb5-8e96-46d9-8717-23951594a9fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA070172
- Marketing category
- ANDA
- Marketing start
- 2005-09-23
- 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 | 1191234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-1782-03 | Naloxone Hydrochloride | 1 mL in 1 CARTRIDGE | INJECTION, SOLUTION | 1 | | 23 |
| 0409-1782-69 | Naloxone Hydrochloride | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NALOXONE HYDROCHLORIDE | ACTIVE INGREDIENT | F850569PQR | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| NALOXONE | ACTIVE MOIETY | 36B82AMQ7N | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| NALOXONE HYDROCHLORIDE | ACTIVE INGREDIENT | F850569PQR | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| NALOXONE | ACTIVE MOIETY | 36B82AMQ7N | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-1782 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 23 | Current NDC, Legacy NDC, 2 package rows | 20230607_b598c237-032d-4bb5-0e92-50eabd863dac.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 |
|---|
| 0409-1782-03 | 00409178203 | 1 mL in 1 CARTRIDGE | 1 ml | | | | | Historical |
| 0409-1782-69 | 00409178269 | 10 CARTRIDGE in 1 BOX (0409-1782-69) / 1 mL in 1 CARTRIDGE (0409-1782-03) | 10 cartridge | 2005-09-23 | 0000-00-00 | No | No | Current |