Moxifloxacin Ophthalmic Solution
- Product NDC
- 68083-210
- 11-digit product format
- 680830210
- Labeler code
- 68083
- Product ID
- 68083-210_1762525e-0af9-445f-ab67-00bfa954dc7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Moxifloxacin Ophthalmic
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA208778
- Marketing category
- ANDA
- Marketing start
- 2020-03-30
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [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 |
|---|
| 68083-210-01 | Moxifloxacin Ophthalmic Solution | 3 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 3 | | 4 |
| 68083-210-01 | Moxifloxacin Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-210 | MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN OPHTHALMIC) SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20200611_95773bca-0791-4bfe-955a-4d2fa4561e01.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 |
|---|
| 68083-210-01 | 68083021001 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-210-01) / 3 mL in 1 BOTTLE, PLASTIC | 2020-03-30 | 0000-00-00 | No | No | Current |