Ofloxacin
- Product NDC
- 33261-737
- 11-digit product format
- 332610737
- Labeler code
- 33261
- Product ID
- 33261-737_716cfc62-96c0-46e2-aa7c-a8093b793195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA076128
- Marketing category
- ANDA
- Marketing start
- 2008-03-17
- Marketing end
- 0000-00-00
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f9d82093-3de1-4841-9a42-67222d61a0cf | Product name | 4 | 20250515 |
| bbed5f06-a6b7-a443-70ac-77518a9524b7 | Product name | 7 | 20250311 |
| 41679fed-052c-574b-6b40-cadcbc315b79 | Product name | 2 | 20150401 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-737-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a273-f424-e053-dadaa90a57ce | Ofloxacin Otic Solution 0.3% (Sterile) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-737-01 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | 1 | |
| 33261-737-01 | Ofloxacin | 1 in 1 CARTON | SOLUTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-737-01 | ML - Milliliter | 33261-737 | f766c15b-0e28-4620-aef6-57ee72c6c58e | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN SOLUTION [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 242446 | ofloxacin 0.3 % Otic Solution | PSN | d02d88ba-1c90-4f82-bc94-4ad3c9918cb1 | 1 |
| 242446 | ofloxacin 3 MG/ML Otic Solution | SCD | d02d88ba-1c90-4f82-bc94-4ad3c9918cb1 | 1 |
| 242446 | ofloxacin 0.3 % Otic Solution | SY | d02d88ba-1c90-4f82-bc94-4ad3c9918cb1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 33261-737-01 | 33261073701 | 5 mL in 1 BOTTLE, DROPPER | 5 ml | Historical |