NALOXONE HYDROCHLORIDE
- Product NDC
- 46122-812
- 11-digit product format
- 461220812
- Labeler code
- 46122
- Product ID
- 46122-812_7232f412-39b6-47d5-8f9a-0c1559435a3f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- AMERISOURCE BERGEN
- Application
- ANDA211951
- Marketing category
- ANDA
- Marketing start
- 2025-03-12
- 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 |
|---|
| 46122-812-71 | NALOXONE HYDROCHLORIDE | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 2 |
| 46122-812-71 | NALOXONE HYDROCHLORIDE | 2 in 1 CARTON | SPRAY | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-812 | NALOXONE HYDROCHLORIDE SPRAY [AMERISOURCE BERGEN] | 1 | Current NDC, 2 package rows | 20250313_cce38c13-0d2f-49bb-94fa-6f2bbb4d5984.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46122-812-71 | 46122081271 | 2 VIAL, SINGLE-DOSE in 1 CARTON (46122-812-71) / .1 mL in 1 VIAL, SINGLE-DOSE | 2025-03-12 | No | No | Historical |