Naloxone Hydrochloride
- Product NDC
- 71288-814
- 11-digit product format
- 712880814
- Labeler code
- 71288
- Product ID
- 71288-814_cedd8237-fb6c-48a4-81da-156d09b01943
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA214211
- Marketing category
- ANDA
- Marketing start
- 2026-01-01
- Marketing end
- 2026-06-01
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 mg/mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-814-81 | Naloxone Hydrochloride | 1 mL in 1 SYRINGE | INJECTION | 1 | | 2 |
| 71288-814-81 | Naloxone Hydrochloride | 10 in 1 CARTON | INJECTION | 10 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-814-81 | 71288081481 | 10 SYRINGE in 1 CARTON (71288-814-81) / 1 mL in 1 SYRINGE | 10 syringe | 2026-01-01 | 2026-06-01 | No | No | Historical |