Olfoxacin Otic Soln
- Product NDC
- 72189-490
- 11-digit product format
- 721890490
- Labeler code
- 72189
- Product ID
- 72189-490_4d3aa53c-878c-d447-e063-6394a90a6a31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olfoxacin Otic Soln
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Direct_Rx
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2023-06-08
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olfoxacin Otic Soln
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OFLOXACIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 242446 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-490-05 | Olfoxacin Otic Soln | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-490 | OLFOXACIN OTIC SOLN SOLUTION [DIRECT_RX] | 2 | Current NDC, 1 package rows | 20250123_fda35d37-f36a-efc8-e053-6294a90a2bb8.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 |
|---|
| 72189-490-05 | 72189049005 | 5 mL in 1 BOTTLE, DROPPER (72189-490-05) | 5 ml | 2023-06-08 | No | No | Current |