MOXIFLOXACIN
- Product NDC
- 65862-840
- 11-digit product format
- 658620840
- Labeler code
- 65862
- Product ID
- 65862-840_95a06b0b-fd23-4b1b-9813-105678b10b6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MOXIFLOXACIN
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- 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 |
|---|
| 65862-840-03 | MOXIFLOXACIN | 3 mL in 1 BOTTLE | SOLUTION/ DROPS | 3 | | 7 |
| 65862-840-03 | MOXIFLOXACIN | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-840 | MOXIFLOXACIN SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241115_8877013d-9b49-40f7-a2c4-99bb519e104e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-840-03 | 65862084003 | 1 BOTTLE in 1 CARTON (65862-840-03) / 3 mL in 1 BOTTLE | 1 bottle | 2017-10-04 | 0000-00-00 | No | No | Current |