Naloxone Hydrochloride
- Product NDC
- 0404-9920
- 11-digit product format
- 004049920
- Labeler code
- 0404
- Product ID
- 0404-9920_60d937e9-a110-40d3-983d-f445518702a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA070172
- Marketing category
- ANDA
- Marketing start
- 2022-01-13
- 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 | 1191234 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0404-9920-01 | Naloxone Hydrochloride | 1 in 1 BAG | INJECTION, SOLUTION | 1 | | 5 |
| 0404-9920-01 | Naloxone Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9920 | NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HENRY SCHEIN, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250129_d39635a4-ddb3-4d32-8211-eb84c78e9f59.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 |
|---|
| 0404-9920-01 | 00404992001 | 1 BOX in 1 BAG (0404-9920-01) / 1 CARTRIDGE in 1 BOX / 1 mL in 1 CARTRIDGE | 1 box | 2022-01-13 | 0000-00-00 | No | No | Current |