CIPRODEX
- Product NDC
- 0078-0799
- 11-digit product format
- 000780799
- Labeler code
- 0078
- Product ID
- 0078-0799_535b147b-58b1-4027-8126-0b64be0ed6b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin and dexamethasone
- Dosage form
- SUSPENSION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021537
- Marketing category
- NDA
- Marketing start
- 2003-08-04
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE; DEXAMETHASONE
- Active strength
- 3 mg/mL; mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0799 | CIPRODEX (CIPROFLOXACIN AND DEXAMETHASONE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] | 6 | Legacy NDC | 20230627_3e2cf3ea-a8f2-42e3-8424-9a6d6f0a4cb3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0799-75 | 00078079975 | 1 BOTTLE in 1 CARTON (0078-0799-75) > 7.5 mL in 1 BOTTLE | 1 bottle | 2020-07-28 | 0000-00-00 | No | No | Current |
| 0078-0799-98 | 00078079998 | 1 BOTTLE in 1 CARTON (0078-0799-98) > .5 mL in 1 BOTTLE | 1 bottle | 2020-07-28 | 0000-00-00 | Yes | No | Current |