ofloxacin
- Product NDC
- 72603-186
- 11-digit product format
- 726030186
- Labeler code
- 72603
- Product ID
- 72603-186_1831737e-5035-4daf-9924-5a29ebb6b433
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin otic
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- NorthStar RxLLC
- Application
- ANDA216130
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- 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
- 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 |
|---|
| 72603-186-01 | ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 1 |
| 72603-186-02 | ofloxacin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-186 | OFLOXACIN (OFLOXACIN OTIC) SOLUTION [NORTHSTAR RXLLC] | 1 | Current NDC, 2 package rows | 20231201_b95114f6-6753-4217-b621-44fa34afc298.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-186-01 | 72603018601 | 5 mL in 1 BOTTLE, DROPPER (72603-186-01) | 5 ml | 2023-12-01 | No | No | Historical |
| 72603-186-02 | 72603018602 | 10 mL in 1 BOTTLE, DROPPER (72603-186-02) | 10 ml | 2023-12-01 | No | No | Historical |