NALOXONE HYDROCHLORIDE
- Product NDC
- 0404-9773
- 11-digit product format
- 004049773
- Labeler code
- 0404
- Product ID
- 0404-9773_dfa64508-45a2-41b2-b20f-eccda5e05c29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA218404
- Marketing category
- ANDA
- Marketing start
- 2025-10-28
- 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
openFDA Listing Details
- Product ID
- 0404-9773_dfa64508-45a2-41b2-b20f-eccda5e05c29
- SPL ID
- dfa64508-45a2-41b2-b20f-eccda5e05c29
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- NALOXONE HYDROCHLORIDE
- Generic name
- naloxone hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Marketing start
- 2025-10-28
- Marketing category
- ANDA
- Application number
- ANDA218404
- Pharmacologic classes
- Opioid Antagonist [EPC]; Opioid Antagonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | .4 mg/mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1659929 |
| Spl Set Id | ddeebc32-9aab-4a2f-8c87-74335d17d5ef |
| Manufacturer Name | Henry Schein, Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 0404-9773-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-10-28 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| F850569PQR | NALOXONE HYDROCHLORIDE | 357-08-4 | NALOXONE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9773-01 | 00404977301 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-10-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naloxone Hydrochloride | Henry Schein, Inc. | 2025-10-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |