Ciprofloxacin and Dexamethasone
- Product NDC
- 16714-628
- 11-digit product format
- 167140628
- Labeler code
- 16714
- Product ID
- 16714-628_6fc9db70-e09e-2b14-8c39-98bee524acad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin and Dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- NorthStar RxLLC
- Application
- ANDA205548
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- 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 |
|---|
| 16714-628-01 | Ciprofloxacin and Dexamethasone | 7.5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 7.5 | | 3 |
| 16714-628-01 | Ciprofloxacin and Dexamethasone | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-628 | CIPROFLOXACIN AND DEXAMETHASONE SUSPENSION/ DROPS [NORTHSTAR RXLLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241115_130deaf4-ced5-abcb-2a01-205c640ddf96.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 |
|---|
| 16714-628-01 | 16714062801 | 1 BOTTLE, DROPPER in 1 CARTON (16714-628-01) / 7.5 mL in 1 BOTTLE, DROPPER | 2022-08-01 | 0000-00-00 | No | No | Current |