ciprofloxacin hydrochloride and hydrocortisone
- Product NDC
- 0713-0851
- 11-digit product format
- 007130851
- Labeler code
- 0713
- Product ID
- 0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin hydrochloride and hydrocortisone
- Dosage form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA218273
- Marketing category
- ANDA
- Marketing start
- 2025-12-04
- Substance
- CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
- Active strength
- 2; 10 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 hydrochloride and hydrocortisone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN HYDROCHLORIDE | 2 mg/mL |
| HYDROCORTISONE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4BA73M5E37, WI4X0X7BPJ |
| Rxcui | 309305 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0851-09 | ciprofloxacin hydrochloride and hydrocortisone | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | | 1 |
| 0713-0851-09 | ciprofloxacin hydrochloride and hydrocortisone | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0851-09 | 00713085109 | 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE | 1 bottle | 2025-12-04 | No | No | Historical |