ofloxacin
- Product NDC
- 68071-3448
- 11-digit product format
- 680713448
- Labeler code
- 68071
- Product ID
- 68071-3448_1ef20a94-8557-bb67-e063-6394a90afc6c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA215886
- Marketing category
- ANDA
- Marketing start
- 2022-12-07
- 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 |
|---|
| 68071-3448-5 | ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 68071-3448-5 | ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3448 | OFLOXACIN SOLUTION/ DROPS [NUCARE PHARMACEUTICALS,INC.] | 2 | Current NDC, 2 package rows | 20240806_ff9776b3-a244-e1ea-e053-6294a90aeb7b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3448-5 | 68071344805 | 1 BOTTLE, DROPPER in 1 CARTON (68071-3448-5) / 5 mL in 1 BOTTLE, DROPPER | 2023-07-03 | No | No | Current |