NALOXONE HYDROCHLORIDE
- Product NDC
- 45802-578
- 11-digit product format
- 458020578
- Labeler code
- 45802
- Product ID
- 45802-578_10534467-f259-44bb-bdf7-b09de54411ed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA211951
- Marketing category
- ANDA
- Marketing start
- 2023-07-30
- 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 |
|---|
| 45802-578-00 | NALOXONE HYDROCHLORIDE | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 5 |
| 45802-578-24 | NALOXONE HYDROCHLORIDE | 24 in 1 CARTON | SPRAY | 24 | | 5 |
| 45802-578-84 | 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 |
|---|
| 45802-578 | NALOXONE HYDROCHLORIDE SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 2 | Current NDC, 3 package rows | 20240730_b5d40220-f194-4835-b70c-f304ecb222d5.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 |
|---|
| 45802-578-00 | 45802057800 | 0.1 mL in 1 VIAL, SINGLE-DOSE | 0.1 ml | | | | Historical |
| 45802-578-24 | 45802057824 | 24 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-24) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00) | | 2025-08-01 | No | No | Current |
| 45802-578-84 | 45802057884 | 2 VIAL, SINGLE-DOSE in 1 CARTON (45802-578-84) / .1 mL in 1 VIAL, SINGLE-DOSE (45802-578-00) | | 2023-07-30 | No | No | Current |