Naloxone Hydrochloride
- Product NDC
- 54288-124
- 11-digit product format
- 542880124
- Labeler code
- 54288
- Product ID
- 54288-124_f0223f84-ddc4-45a8-94e8-22cd1a39f19e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- BPI Labs LLC
- Application
- ANDA216977
- Marketing category
- ANDA
- Marketing start
- 2023-11-15
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 1 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191250 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54288-124 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [BPI LABS LLC] | 3 | Current NDC | 20250213_5de44ee7-6525-4857-9a67-8882e96dbeb5.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 |
|---|
| 54288-124-01 | 54288012401 | 1 PACKAGE in 1 CARTON (54288-124-01) / 2 mL in 1 PACKAGE | 1 package | 2023-11-15 | No | No | Current |
| 54288-124-10 | 54288012410 | 10 PACKAGE in 1 CARTON (54288-124-10) / 2 mL in 1 PACKAGE | 10 package | 2023-11-15 | No | No | Current |