NALOXONE HYDROCHLORIDE
- Product NDC
- 71205-707
- 11-digit product format
- 712050707
- Labeler code
- 71205
- Product ID
- 71205-707_8d529b4c-85fd-4e50-9443-9080825307bf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Proficient Rx LP
- Application
- ANDA211951
- Marketing category
- ANDA
- Marketing start
- 2022-06-21
- 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 |
|---|
| 71205-707-02 | NALOXONE HYDROCHLORIDE | 2 in 1 CARTON | SPRAY | 2 | | 1 |
| 71205-707-02 | NALOXONE HYDROCHLORIDE | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-707 | NALOXONE HYDROCHLORIDE SPRAY [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221021_8d529b4c-85fd-4e50-9443-9080825307bf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-707-02 | 71205070702 | 2 VIAL, SINGLE-DOSE in 1 CARTON (71205-707-02) / .1 mL in 1 VIAL, SINGLE-DOSE | 2022-10-20 | 0000-00-00 | No | No | Current |