Ofloxacin
- Product NDC
- 50090-5670
- 11-digit product format
- 500905670
- Labeler code
- 50090
- Product ID
- 50090-5670_8465d7c3-7bb5-409f-9798-b2b55c5a4030
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin Otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- A-S Medication Solutions
- Application
- ANDA211525
- Marketing category
- ANDA
- Marketing start
- 2020-03-17
- 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 | 242446 |
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 |
|---|
| 50090-5670-0 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 6 |
| 50090-5670-0 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5670 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240123_d89fa470-c98b-433a-829b-abe97eb66419.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 |
|---|
| 50090-5670-0 | 50090567000 | 1 BOTTLE, DROPPER in 1 CARTON (50090-5670-0) / 5 mL in 1 BOTTLE, DROPPER | 2021-09-15 | 0000-00-00 | No | No | Current |