Ciprofloxacin Otic
- Product NDC
- 64950-381
- 11-digit product format
- 649500381
- Labeler code
- 64950
- Product ID
- 64950-381_3f726b10-ef7b-47d6-96c9-e1a7ee5461d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Genus Lifesciences
- Application
- ANDA217887
- Marketing category
- ANDA
- Marketing start
- 2024-12-01
- Substance
- CIPROFLOXACIN
- Active strength
- .5 mg/.25mL
- Pharmacologic classes
- 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 Otic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CIPROFLOXACIN | .5 mg/.25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5E8K9I0O4U |
| Rxcui | 848956 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64950-381-14 | Ciprofloxacin Otic | 0.25 mL in 1 VIAL | SOLUTION/ DROPS | 0.25 | | 1 |
| 64950-381-14 | Ciprofloxacin Otic | 14 in 1 CARTON | SOLUTION/ DROPS | 14 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64950-381 | CIPROFLOXACIN OTIC (CIPROFLOXACIN) SOLUTION/ DROPS [GENUS LIFESCIENCES] | 1 | Current NDC, 2 package rows | 20250417_51dde3f2-adb1-4ed8-83c6-1f63723a2529.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 64950-381-14 | 64950038114 | 14 VIAL in 1 CARTON (64950-381-14) / .25 mL in 1 VIAL | 14 vial | 2024-12-01 | No | No | Historical |