ofloxacin
- Product NDC
- 70756-609
- 11-digit product format
- 707560609
- Labeler code
- 70756
- Product ID
- 70756-609_7556cd96-134e-4aaa-bf2d-7b6f9c8133c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Lifestar Pharma LLC
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2022-07-15
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70756-609-15 | ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70756-609 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION [LIFESTAR PHARMA LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20230625_0621700e-6315-47ff-a8ed-cccf7d6fc56a.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 |
|---|
| 70756-609-15 | 70756060915 | 5 mL in 1 BOTTLE, DROPPER (70756-609-15) | 5 ml | 2022-07-15 | 0000-00-00 | No | No | Current |