Naloxone Hydrochloride
- Product NDC
- 43598-750
- 11-digit product format
- 435980750
- Labeler code
- 43598
- Product ID
- 43598-750_6558760c-9e5d-caa4-7786-efca221e56f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Dr. Reddy's Laboratories, Inc.
- Application
- ANDA213209
- Marketing category
- ANDA
- Marketing start
- 2020-03-18
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-750 | NALOXONE HYDROCHLORIDE INJECTION [DR. REDDY'S LABORATORIES, INC.] | 7 | Current NDC, Legacy NDC | 20240912_b1303f15-c48b-a44d-b28a-72f370094e02.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 |
|---|
| 43598-750-10 | 43598075010 | 10 SYRINGE in 1 BOX (43598-750-10) / 2 mL in 1 SYRINGE | 10 syringe | 2024-09-10 | | No | No | Historical |
| 43598-750-11 | 43598075011 | 1 SYRINGE in 1 BOX (43598-750-11) / 2 mL in 1 SYRINGE | 1 syringe | 2020-03-18 | 0000-00-00 | No | No | Current |
| 43598-750-58 | 43598075058 | 10 SYRINGE in 1 BOX (43598-750-58) > 2 mL in 1 SYRINGE | 10 syringe | 2020-03-18 | 0000-00-00 | No | No | Current |