OFLOXACIN OTIC
- Product NDC
- 72189-108
- 11-digit product format
- 721890108
- Labeler code
- 72189
- Product ID
- 72189-108_4d3a96c7-d9da-c351-e063-6394a90a680d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OFLOXACIN
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- DIRECT RX
- Application
- ANDA076527
- Marketing category
- ANDA
- Marketing start
- 2020-06-08
- 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
- OFLOXACIN OTIC
- 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 |
|---|
| 72189-108-05 | OFLOXACIN OTIC | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-108 | OFLOXACIN OTIC (OFLOXACIN) SOLUTION [DIRECT RX] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250119_a7952956-b64a-0f99-e053-2995a90a0f91.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 |
|---|
| 72189-108-05 | 72189010805 | 5 mL in 1 BOTTLE, DROPPER (72189-108-05) | 5 ml | 2020-06-08 | 0000-00-00 | No | No | Current |