MOXIFLOXACIN
- Product NDC
- 82804-055
- 11-digit product format
- 828040055
- Labeler code
- 82804
- Product ID
- 82804-055_c38e051f-5765-4066-9953-2d0832481b1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MOXIFLOXACIN
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA206242
- Marketing category
- ANDA
- Marketing start
- 2017-10-04
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MOXIFLOXACIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MOXIFLOXACIN HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C53598599T |
| Rxcui | 403818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-055-03 | MOXIFLOXACIN | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 1 |
| 82804-055-03 | MOXIFLOXACIN | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-055 | MOXIFLOXACIN SOLUTION/ DROPS [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20240112_c38e051f-5765-4066-9953-2d0832481b1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-055-03 | 82804005503 | 1 BOTTLE in 1 CARTON (82804-055-03) / 3 mL in 1 BOTTLE | 1 bottle | 2024-01-09 | No | No | Current |