Moxifloxacin ophthalmic solution
- Product NDC
- 46708-505
- 11-digit product format
- 467080505
- Labeler code
- 46708
- Product ID
- 46708-505_09d80c83-4b62-47a1-a3d7-6352bc6a79cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Moxifloxacin ophthalmic solution
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA209469
- Marketing category
- ANDA
- Marketing start
- 2019-02-13
- 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 ophthalmic solution
- 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 |
|---|
| 46708-505-03 | Moxifloxacin ophthalmic solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 46708-505-03 | Moxifloxacin ophthalmic solution | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-505 | MOXIFLOXACIN OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 2 package rows | 20240420_fee8323d-bcb0-4f49-a06d-2ed597a7b2ac.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 |
|---|
| 46708-505-03 | 46708050503 | 1 BOTTLE in 1 CARTON (46708-505-03) / 3 mL in 1 BOTTLE | 1 bottle | 2019-02-13 | No | No | Current |