NALOXONE HYDROCHLORIDE
- Product NDC
- 0404-9922
- 11-digit product format
- 004049922
- Labeler code
- 0404
- Product ID
- 0404-9922_ace20fdd-3422-48d9-acf4-da37f78f13a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxone hydrochloride
- Dosage form
- INJECTION
- Route
- PARENTERAL
- Labeler
- Henry Schein, Inc
- Application
- ANDA072076
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 1191250 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9922-02 | NALOXONE HYDROCHLORIDE | 2 mL in 1 SYRINGE | INJECTION | 2 | | 10 |
| 0404-9922-02 | NALOXONE HYDROCHLORIDE | 1 in 1 BAG | INJECTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9922 | NALOXONE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240605_bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc.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 |
|---|
| 0404-9922-02 | 00404992202 | 1 SYRINGE in 1 BAG (0404-9922-02) / 2 mL in 1 SYRINGE | 1 syringe | 2022-01-13 | 0000-00-00 | No | No | Current |