Moxifloxacin Hydrochloride
- Product NDC
- 76420-331
- 11-digit product format
- 764200331
- Labeler code
- 76420
- Product ID
- 76420-331_331b69c5-5ad7-a90a-e063-6394a90acfd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Moxifloxacin Hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA212616
- Marketing category
- ANDA
- Marketing start
- 2021-02-10
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| C53598599T | MOXIFLOXACIN HYDROCHLORIDE | 186826-86-8 | MOXIFLOXACIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-331-03 | 76420033103 | 1 BOTTLE, PLASTIC in 1 CARTON (76420-331-03) / 3 mL in 1 BOTTLE, PLASTIC | 2025-04-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Moxifloxacin Hydrochloride | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-04-19 | HUMAN PRESCRIPTION DRUG LABEL | 1 |