Moxifloxacin
- Product NDC
- 80425-0239
- 11-digit product format
- 804250239
- Labeler code
- 80425
- Product ID
- 80425-0239_2a9aa671-d0a2-2254-e063-6294a90a9f79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Moxifloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA090080
- Marketing category
- ANDA
- Marketing start
- 2023-01-11
- Substance
- MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
- 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 MONOHYDRATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B8956S8609 |
| Rxcui | 403818 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0239-1 | Moxifloxacin | 3 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 3 | | 3 |
| 80425-0239-1 | Moxifloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0239 | MOXIFLOXACIN SOLUTION/ DROPS [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, 2 package rows | 20250102_f19fa89e-9f5d-4eed-e053-2995a90ac3ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0239-1 | 80425023901 | 1 BOTTLE, DROPPER in 1 CARTON (80425-0239-1) / 3 mL in 1 BOTTLE, DROPPER | 2023-01-11 | No | No | Current |