Naloxone Hydrochloride
- Product NDC
- 55150-327
- 11-digit product format
- 551500327
- Labeler code
- 55150
- Product ID
- 55150-327_c0bb9ae0-109a-4e3f-b300-a94e2721dddb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA212455
- Marketing category
- ANDA
- Marketing start
- 2019-10-15
- 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 | 1659929 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-327-10 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 4 |
| 55150-327-10 | Naloxone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 55150-327-25 | Naloxone Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 55150-327-25 | Naloxone Hydrochloride | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-327 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240709_c7fa8d4f-28a7-4ef5-aef8-cbd4328ce599.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-327-10 | 55150032710 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-10) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-10-15 | 0000-00-00 | No | No | Current |
| 55150-327-25 | 55150032725 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-327-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-10-15 | 0000-00-00 | No | No | Current |