Naloxone Hydrochloride
- Product NDC
- 0409-1215
- 11-digit product format
- 004091215
- Labeler code
- 0409
- Product ID
- 0409-1215_2b456953-1487-4550-946e-50c01536c8ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA070256
- Marketing category
- ANDA
- Marketing start
- 2005-07-12
- 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
- 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 | 1191222, 1659929 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-1215-01 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 35 |
| 0409-1215-21 | Naloxone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 35 |
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.] | 12 | |
| NALOXONE | ACTIVE MOIETY | 36B82AMQ7N | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-1215 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 34 | Current NDC, Legacy NDC, 2 package rows | 20250124_8535cc84-ad4a-4d67-8480-fb5a2e3406f8.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 |
|---|
| 0409-1215-01 | 00409121501 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1215-21) | | 2005-07-12 | 0000-00-00 | No | No | Current |
| 0409-1215-21 | 00409121521 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |