Naloxone Hydrochloride
- Product NDC
- 42023-224
- 11-digit product format
- 420230224
- Labeler code
- 42023
- Product ID
- 42023-224_3b2e17da-1874-451c-80eb-1c87a62e585c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Par Health USA, LLC
- Application
- ANDA215964
- Marketing category
- ANDA
- Marketing start
- 2024-11-05
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 1 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 | 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 |
|---|
| 42023-224-01 | Naloxone Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 21 |
| 42023-224-01 | Naloxone Hydrochloride | 2 mL in 1 SYRINGE, GLASS | INJECTION | 2 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-224 | NALOXONE HYDROCHLORIDE INJECTION [ENDO USA, INC.] | 20 | Current NDC, 2 package rows | 20241113_3ae08e26-223b-4971-b2f1-f1e183a3f930.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42023-224-01 | 42023022401 | 1 SYRINGE, GLASS in 1 CARTON (42023-224-01) / 2 mL in 1 SYRINGE, GLASS | 2024-11-05 | No | No | Current |