Naloxone Hydrochloride Injection, USP, Auto-Injector
- Product NDC
- 60842-002
- 11-digit product format
- 608420002
- Labeler code
- 60842
- Product ID
- 60842-002_04afe7f9-83ba-4269-a6ce-3bcc61a106d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; SUBCUTANEOUS
- Labeler
- Kaleo, Inc.
- Application
- NDA215457
- Marketing category
- NDA
- Marketing start
- 2022-02-28
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 10 mg/.4mL
- 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 Injection, USP, Auto-Injector
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | 10 mg/.4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 2596175 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60842-002-02 | Naloxone Hydrochloride Injection, USP, Auto-Injector | 0.4 mL in 1 DOSE PACK | INJECTION, SOLUTION | 0.4 | | 2 |
| 60842-002-02 | Naloxone Hydrochloride Injection, USP, Auto-Injector | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60842-002 | NALOXONE HYDROCHLORIDE INJECTION, USP, AUTO-INJECTOR (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [KALEO, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220315_b5463553-b775-47a3-8d10-31e01ca1ec72.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 |
|---|
| 60842-002-02 | 60842000202 | 10 DOSE PACK in 1 CARTON (60842-002-02) / .4 mL in 1 DOSE PACK | 10 dose pack | 2022-02-28 | 0000-00-00 | No | No | Current |