Ciprofloxacin and Dexamethasone
- Product NDC
- 53746-831
- 11-digit product format
- 537460831
- Labeler code
- 53746
- Product ID
- 53746-831_718cd533-d887-4ef1-a7d0-fca696242bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin and Dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA216501
- Marketing category
- ANDA
- Marketing start
- 2024-03-26
- Substance
- CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
- Active strength
- 3; 1 mg/mL; mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Cytochrome P450 1A2 Inhibitors [MoA], 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
- Ciprofloxacin and Dexamethasone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 3 mg/mL |
| DEXAMETHASONE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BA73M5E37, 7S5I7G3JQL |
| Rxcui | 403908 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-831-53 | Ciprofloxacin and Dexamethasone | 7.5 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 7.5 | | 7 |
| 53746-831-53 | Ciprofloxacin and Dexamethasone | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-831 | CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 7 | Current NDC, 2 package rows | 20240328_55426495-5fd1-44ca-afcc-ffbbb0a0a569.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 53746-831-53 | 53746083153 | 1 BOTTLE, PLASTIC in 1 CARTON (53746-831-53) / 7.5 mL in 1 BOTTLE, PLASTIC | 2024-03-26 | No | No | Current |