Ofloxacin
- Product NDC
- 70512-793
- 11-digit product format
- 705120793
- Labeler code
- 70512
- Product ID
- 70512-793_4572865e-3ba3-c17b-e063-6294a90a97fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin Ophthalmic Solution USP, 0.3%
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- SOLA Pharmaceuticals, LLC
- Application
- ANDA217904
- Marketing category
- ANDA
- Marketing start
- 2024-04-30
- 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 |
|---|
| 70512-793-05 | Ofloxacin | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 3 |
| 70512-793-05 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 3 |
| 70512-793-10 | Ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 3 |
| 70512-793-10 | Ofloxacin | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70512-793 | OFLOXACIN (OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%) SOLUTION/ DROPS [SOLA PHARMACEUTICALS, LLC] | 2 | Current NDC, 4 package rows | 20240430_4ca27244-ed70-4868-b2d8-8f97c3a52148.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70512-793-05 | 70512079305 | 1 BOTTLE, DROPPER in 1 BOX (70512-793-05) / 5 mL in 1 BOTTLE, DROPPER | 2024-04-30 | No | No | Current |
| 70512-793-10 | 70512079310 | 1 BOTTLE, DROPPER in 1 BOX (70512-793-10) / 10 mL in 1 BOTTLE, DROPPER | 2024-04-30 | No | No | Current |