Ciprofloxacin Otic
- Product NDC
- 42195-550
- 11-digit product format
- 421950550
- Labeler code
- 42195
- Product ID
- 42195-550_613cf17e-578a-4530-ac73-179d72a9e415
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CIPROFLOXACIN
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Xspire Pharma, Llc
- Application
- NDA021918
- Marketing category
- NDA
- Marketing start
- 2012-08-27
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 1 mg/.25mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42195-550-14 | Ciprofloxacin Otic | 0.25 mL in 1 CONTAINER | SOLUTION/ DROPS | 0.25 | | 6 |
| 42195-550-14 | Ciprofloxacin Otic | 14 in 1 CARTON | SOLUTION/ DROPS | 14 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42195-550 | CIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [XSPIRE PHARMA, LLC] | 6 | Legacy NDC, 2 package rows | 20241011_d0125acf-1879-452d-ba29-c0f753653789.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 |
|---|
| 42195-550-14 | 42195055014 | 14 CONTAINER in 1 CARTON (42195-550-14) > .25 mL in 1 CONTAINER | 14 container | 2012-08-27 | 0000-00-00 | No | No | Current |