KLOXXADO
- Product NDC
- 59467-679
- 11-digit product format
- 594670679
- Labeler code
- 59467
- Product ID
- 59467-679_da424329-9a63-4df3-bced-4157d2086e20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naloxone HCL
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Hikma Specialty USA Inc.
- Application
- NDA212045
- Marketing category
- NDA
- Marketing start
- 2021-08-03
- Substance
- NALOXONE HYDROCHLORIDE
- Active strength
- 8 mg/.1mL
- 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
- KLOXXADO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALOXONE HYDROCHLORIDE | 8 mg/.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F850569PQR |
| Rxcui | 2540703, 2540709 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59467-679-01 | KLOXXADO | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59467-679 | KLOXXADO (NALOXONE HCL) SPRAY [HIKMA SPECIALTY USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240531_ebf0f833-c1c0-487c-8f29-01fa8c61b6cb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59467-679-01 | 59467067901 | .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01) | 2021-08-03 | 0000-00-00 | No | No | Current |