Naloxone Hydrochloride
- Product NDC
- 0591-3871
- 11-digit product format
- 005913871
- Labeler code
- 0591
- Product ID
- 0591-3871_2c4bb622-fc96-4877-92c8-a15be1636137
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA209522
- Marketing category
- ANDA
- Marketing start
- 2025-01-17
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 4 mg/.1mL
- 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/.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1725059 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-3871-54 | Naloxone Hydrochloride | 1 in 1 BLISTER PACK | SPRAY, METERED | 1 | | 1 |
| 0591-3871-54 | Naloxone Hydrochloride | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY, METERED | 0.1 | | 1 |
| 0591-3871-99 | Naloxone Hydrochloride | 2 in 1 CARTON | SPRAY, METERED | 2 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0591-3871-54 | 00591387154 | 1 in 1 BLISTER PACK | | | | | Historical |
| 0591-3871-99 | 00591387199 | 2 BLISTER PACK in 1 CARTON (0591-3871-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-3871-54) / .1 mL in 1 VIAL, SINGLE-DOSE | 2 blister pack | 2025-01-17 | No | No | Current |