Ofloxacin
- Product NDC
- 60505-0560
- 11-digit product format
- 605050560
- Labeler code
- 60505
- Product ID
- 60505-0560_9fc163d2-e518-3e95-f589-2ad375775998
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA076513
- Marketing category
- ANDA
- Marketing start
- 2019-03-01
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC], Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ofloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OFLOXACIN | 3 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A4P49JAZ9H |
| Rxcui | 312075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-0560-0 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
| 60505-0560-0 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 12 |
| 60505-0560-1 | Ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 12 |
| 60505-0560-1 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-0560 | OFLOXACIN SOLUTION [APOTEX CORP.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241105_5117d567-2004-c5ed-1391-f8831864696f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-0560-0 | 60505056000 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPER | 2019-03-01 | 0000-00-00 | No | No | Current |
| 60505-0560-1 | 60505056001 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPER | 2019-03-01 | 0000-00-00 | No | No | Current |