NALOXONE HYDROCHLORIDE
- Product NDC
- 36000-310
- 11-digit product format
- 360000310
- Labeler code
- 36000
- Product ID
- 36000-310_bde02e6f-da64-4b2b-80f2-2c0ab9783483
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NALOXONE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA214792
- Marketing category
- ANDA
- Marketing start
- 2022-11-07
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- .4 mg/mL
- 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/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36000-310-01 | NALOXONE HYDROCHLORIDE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 36000-310-02 | NALOXONE HYDROCHLORIDE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36000-310 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240921_3d8813be-6d22-46f1-ac25-0d8a817a521c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36000-310-01 | 36000031001 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 36000-310-02 | 36000031002 | 1 VIAL, MULTI-DOSE in 1 CARTON (36000-310-02) / 10 mL in 1 VIAL, MULTI-DOSE (36000-310-01) | | 2022-11-07 | 0000-00-00 | No | No | Current |