Ofloxacin
- Product NDC
- 50090-5425
- 11-digit product format
- 500905425
- Labeler code
- 50090
- Product ID
- 50090-5425_73ce8dc2-0fdd-4b1c-b144-9a7a3ded8b80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- ANDA078559
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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
- 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 | 312075 |
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 |
|---|
| 50090-5425-0 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 50090-5425-0 | Ofloxacin | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5425 | OFLOXACIN SOLUTION [A-S MEDICATION SOLUTIONS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241025_537c6351-c7f1-47c9-95de-011bac850768.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 |
|---|
| 50090-5425-0 | 50090542500 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-5425-0) / 5 mL in 1 BOTTLE, PLASTIC | 2021-01-08 | 0000-00-00 | No | No | Current |