ofloxacin
- Product NDC
- 70756-607
- 11-digit product format
- 707560607
- Labeler code
- 70756
- Product ID
- 70756-607_a68adde3-7458-4a12-9aea-537d6ce5f144
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Lifestar Pharma LLC
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ofloxacin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OFLOXACIN | 3 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | A4P49JAZ9H |
| Rxcui | 312075 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70756-607-30 | ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 10 | |
| 70756-607-30 | ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70756-607-30 | ML - Milliliter | 70756-607 | 9b6185fb-7815-4294-9d22-d7650b1afac6 | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 871d63f4-41c1-4b30-903c-11fbf0d4c1f8 | 10 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 871d63f4-41c1-4b30-903c-11fbf0d4c1f8 | 10 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 871d63f4-41c1-4b30-903c-11fbf0d4c1f8 | 10 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | d97651cc-d9ea-4be4-8ea1-3d0278582dd5 | 7 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | d97651cc-d9ea-4be4-8ea1-3d0278582dd5 | 7 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | d97651cc-d9ea-4be4-8ea1-3d0278582dd5 | 7 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 306ed758-3c43-4f42-bd44-562ec65891dc | 3 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | fc4d4b14-1eeb-0fba-e053-6394a90a738e | 3 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | fc4d4b14-1eeb-0fba-e053-6394a90a738e | 3 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 306ed758-3c43-4f42-bd44-562ec65891dc | 3 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 306ed758-3c43-4f42-bd44-562ec65891dc | 3 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | fc4d4b14-1eeb-0fba-e053-6394a90a738e | 3 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | ff9776b3-a244-e1ea-e053-6294a90aeb7b | 2 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | ff9776b3-a244-e1ea-e053-6294a90aeb7b | 2 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | ff9776b3-a244-e1ea-e053-6294a90aeb7b | 2 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 48dc8354-9a36-427b-ade9-818db6bfb01b | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 0c4e0b81-a344-4678-97d2-b15dc2857882 | 1 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 48dc8354-9a36-427b-ade9-818db6bfb01b | 1 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 0c4e0b81-a344-4678-97d2-b15dc2857882 | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 48dc8354-9a36-427b-ade9-818db6bfb01b | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 0c4e0b81-a344-4678-97d2-b15dc2857882 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70756-607-30 | 70756060730 | 1 BOTTLE, DROPPER in 1 CARTON (70756-607-30) / 5 mL in 1 BOTTLE, DROPPER | 2022-12-07 | 0000-00-00 | No | No | Current |