Ofloxacin
- Product NDC
- 21695-439
- 11-digit product format
- 216950439
- Labeler code
- 21695
- Product ID
- 21695-439_7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076622
- Marketing category
- ANDA
- Marketing start
- 2004-05-14
- Marketing end
- 0000-00-00
- Substance
- OFLOXACIN
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 21695-439-05 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a1f-48b1-e053-8cdaa90a720a | Ofloxacin Ophthalmic Solution 0.3% (Sterile) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-439-05 | Ofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 | |
| 21695-439-05 | Ofloxacin | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-439-05 | ML - Milliliter | 21695-439 | 0e8a5703-9743-4c10-a20c-cf9552f8d34e | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OFLOXACIN | ACTIVE INGREDIENT | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| OFLOXACIN | ACTIVE MOIETY | A4P49JAZ9H | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OFLOXACIN SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | PSN | 7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71 | 1 |
| 312075 | ofloxacin 3 MG/ML Ophthalmic Solution | SCD | 7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71 | 1 |
| 312075 | ofloxacin 0.3 % Ophthalmic Solution | SY | 7bfa54ff-9a72-45e1-8fe5-e8411f8c6e71 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-439-05 | 21695043905 | 1 in 1 CARTON | Historical |