Naloxone Hydrochloride
- Product NDC
- 51316-210
- 11-digit product format
- 513160210
- Labeler code
- 51316
- Product ID
- 51316-210_3c18b06c-be22-4076-84f8-80610dda1e61
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- CVS Pharmacy, Inc
- Application
- ANDA217992
- Marketing category
- ANDA
- Marketing start
- 2024-04-24
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 4 mg/.1mL
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naloxone Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 51316-210-01 | Naloxone Hydrochloride | 0.1 mL in 1 VIAL | SPRAY | 0.1 | | 5 |
| 51316-210-02 | Naloxone Hydrochloride | 2 in 1 CARTON | SPRAY | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-210 | NALOXONE HYDROCHLORIDE SPRAY [CVS PHARMACY, INC] | 3 | Current NDC, 2 package rows | 20240426_840e017d-0142-4d0e-a80e-327ac44bc0c5.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 |
|---|
| 51316-210-01 | 51316021001 | 0.1 mL in 1 VIAL | 0.1 ml | | | | Historical |
| 51316-210-02 | 51316021002 | 2 VIAL in 1 CARTON (51316-210-02) / .1 mL in 1 VIAL (51316-210-01) | 2 vial | 2024-04-24 | No | No | Current |