Ofloxacin
- Product NDC
- 64980-515
- 11-digit product format
- 649800515
- Labeler code
- 64980
- Product ID
- 64980-515_8a9b999e-89bc-44ec-b974-729f66dc0bfa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078559
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 64980-515-01 | Ofloxacin | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | 9 | |
| 64980-515-01 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | 9 | |
| 64980-515-05 | Ofloxacin | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 9 | |
| 64980-515-05 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-515-01 | ML - Milliliter | 64980-515 | 2f740d8a-26fe-48ec-b1fa-7be86216dfd9 | 1 | 2015-05-05 |
| 64980-515-05 | ML - Milliliter | 64980-515 | f2910eb4-7b81-4f06-bfc0-617549822144 | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION [RISING PHARMACEUTICALS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | c76d8dc7-9a66-471b-814b-ef7f3605ec93 | 9 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | c76d8dc7-9a66-471b-814b-ef7f3605ec93 | 9 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | c76d8dc7-9a66-471b-814b-ef7f3605ec93 | 9 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 537c6351-c7f1-47c9-95de-011bac850768 | 5 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 537c6351-c7f1-47c9-95de-011bac850768 | 5 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 537c6351-c7f1-47c9-95de-011bac850768 | 5 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | a2089612-de4b-4d78-b311-fa2524bd37f6 | 4 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | a2089612-de4b-4d78-b311-fa2524bd37f6 | 4 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | a2089612-de4b-4d78-b311-fa2524bd37f6 | 4 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 1ece23ae-2d7c-d6d7-e063-6394a90ac3b1 | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 27c247e5-ef93-e9a5-e063-6394a90a2e1e | 1 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 1ece23ae-2d7c-d6d7-e063-6394a90ac3b1 | 1 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 27c247e5-ef93-e9a5-e063-6394a90a2e1e | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 1ece23ae-2d7c-d6d7-e063-6394a90ac3b1 | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 27c247e5-ef93-e9a5-e063-6394a90a2e1e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64980-515-01 | 64980051501 | 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-01) / 10 mL in 1 BOTTLE, PLASTIC | 2017-11-01 | 0000-00-00 | No | No | Current |
| 64980-515-05 | 64980051505 | 1 BOTTLE, PLASTIC in 1 CARTON (64980-515-05) / 5 mL in 1 BOTTLE, PLASTIC | 2017-11-01 | 0000-00-00 | No | No | Current |