Ofloxacin
- Product NDC
- 64980-432
- 11-digit product format
- 649800432
- Labeler code
- 64980
- Product ID
- 64980-432_53f7e16a-6146-4c09-b3bf-4af9984f5b15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA215038
- Marketing category
- ANDA
- Marketing start
- 2022-07-01
- 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
- 2027-12-31
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 |
|---|
| 64980-432-01 | Ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 4 |
| 64980-432-01 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 64980-432-05 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 4 |
| 64980-432-05 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-432 | OFLOXACIN SOLUTION [RISING PHARMA HOLDINGS, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240901_2e912ed6-51e8-40c3-bf10-2af092c63be8.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 |
|---|
| 64980-432-01 | 64980043201 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER | 2022-07-01 | 0000-00-00 | No | No | Current |
| 64980-432-05 | 64980043205 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER | 2022-07-01 | 0000-00-00 | No | No | Current |