Naloxone Hydrochloride
- Product NDC
- 76329-3469
- 11-digit product format
- 763293469
- Labeler code
- 76329
- Product ID
- 76329-3469_2ab20a74-a067-4d43-84fb-fe331192c34b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone Hydrochloride
- Dosage form
- INJECTION
- Route
- PARENTERAL
- Labeler
- International Medication Systems, Limited
- Application
- ANDA072076
- Marketing category
- ANDA
- Marketing start
- 2016-07-28
- 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 |
|---|
| 76329-3469-1 | Naloxone Hydrochloride | 2 mL in 1 SYRINGE | INJECTION | 2 | | 3 |
| 76329-3469-1 | Naloxone Hydrochloride | 10 in 1 BOX | INJECTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76329-3469 | NALOXONE HYDROCHLORIDE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211216_d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54.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 |
|---|
| 76329-3469-1 | 76329346901 | 10 SYRINGE in 1 BOX (76329-3469-1) / 2 mL in 1 SYRINGE | 10 syringe | 2016-07-28 | 0000-00-00 | No | No | Current |