NALOXONE HYDROCHLORIDE
- Product NDC
- 80425-0409
- 11-digit product format
- 804250409
- Labeler code
- 80425
- Product ID
- 80425-0409_1be2d8f6-f643-69a6-e063-6294a90a327f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA211951
- Marketing category
- ANDA
- Marketing start
- 2024-06-27
- 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 |
|---|
| 80425-0409-1 | NALOXONE HYDROCHLORIDE | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 1 |
| 80425-0409-1 | NALOXONE HYDROCHLORIDE | 2 in 1 CARTON | SPRAY | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0409 | NALOXONE HYDROCHLORIDE SPRAY [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20240704_1be2e38b-55ca-abea-e063-6394a90ac548.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0409-1 | 80425040901 | 2 VIAL, SINGLE-DOSE in 1 CARTON (80425-0409-1) / .1 mL in 1 VIAL, SINGLE-DOSE | 2024-06-27 | No | No | Historical |