Moxifloxacin
- Product NDC
- 63323-850
- 11-digit product format
- 633230850
- Labeler code
- 63323
- Product ID
- 63323-850_4070f637-059f-4e3d-8cf3-e5256a46ff3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MOXIFLOXACIN HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA205572
- Marketing category
- NDA
- Marketing start
- 2015-03-18
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 400 mg/250mL
- 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 | 400 mg/250mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C53598599T |
| Rxcui | 351156 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-850-04 | Moxifloxacin | 12 in 1 CASE | INJECTION, SOLUTION | 12 | | 7 |
| 63323-850-74 | Moxifloxacin | 250 mL in 1 BAG | INJECTION, SOLUTION | 250 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MOXIFLOXACIN HYDROCHLORIDE | ACTIVE INGREDIENT | C53598599T | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| MOXIFLOXACIN | ACTIVE MOIETY | U188XYD42P | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM SULFATE | INACTIVE INGREDIENT | 0YPR65R21J | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SULFURIC ACID | INACTIVE INGREDIENT | O40UQP6WCF | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-850 | MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240509_a4e28b09-714b-46e7-b4e6-0163cad78fc5.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 |
|---|
| 63323-850-04 | 63323085004 | 12 BAG in 1 CASE (63323-850-04) / 250 mL in 1 BAG (63323-850-74) | 12 bag | 2015-03-18 | | No | No | Current |
| 63323-850-74 | 63323085074 | 250 mL in 1 BAG (63323-850-74) | 250 ml | 2015-03-18 | 0000-00-00 | No | No | Current |