Ciprofloxacin and Fluocinolone Acetonide
- Product NDC
- 42195-128
- 11-digit product format
- 421950128
- Labeler code
- 42195
- Product ID
- 42195-128_575a0d84-f871-4823-a21b-f439f5fd3802
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin and fluocinolone acetonide
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Xspire Pharma, LLC
- Application
- NDA208251
- Marketing category
- NDA
- Marketing start
- 2021-10-04
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN; FLUOCINOLONE ACETONIDE
- Active strength
- 1 mg/.25mL; mg/.25mL
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42195-128-14 | Ciprofloxacin and Fluocinolone Acetonide | 14 in 1 POUCH | SOLUTION | 14 | | 6 |
| 42195-128-14 | Ciprofloxacin and Fluocinolone Acetonide | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42195-128 | CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE SOLUTION [XSPIRE PHARMA, LLC] | 6 | Legacy NDC, 2 package rows | 20241011_f7664db7-c1aa-4b40-8df8-9cc0b57825f6.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 |
|---|
| 42195-128-14 | 42195012814 | 1 POUCH in 1 CARTON (42195-128-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE | 1 pouch | 2021-10-04 | 0000-00-00 | No | No | Current |