Naloxone Hydrochloride
- Product NDC
- 0363-2140
- 11-digit product format
- 003632140
- Labeler code
- 0363
- Product ID
- 0363-2140_9ae58c12-1542-4a7f-82a2-6e0c989615bd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Walgreen Co.
- 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 |
|---|
| 0363-2140-01 | Naloxone Hydrochloride | 0.1 mL in 1 VIAL | SPRAY | 0.1 | | 4 |
| 0363-2140-02 | Naloxone Hydrochloride | 2 in 1 CARTON | SPRAY | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-2140 | NALOXONE HYDROCHLORIDE SPRAY [WALGREEN CO.] | 2 | Current NDC, 2 package rows | 20240426_3829826b-e48f-4e26-869f-6b9e4ee0a840.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 |
|---|
| 0363-2140-01 | 00363214001 | 0.1 mL in 1 VIAL | 0.1 ml | | | | Historical |
| 0363-2140-02 | 00363214002 | 2 VIAL in 1 CARTON (0363-2140-02) / .1 mL in 1 VIAL (0363-2140-01) | 2 vial | 2024-04-24 | No | No | Historical |