NDC 24208-602
Prolensa
Bromfenac Sodium
Prolensa is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is Bromfenac Sodium.
| Product ID | 24208-602_0e96d63b-fa0b-4bc4-a06f-f33d40358971 |
| NDC | 24208-602 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Prolensa |
| Generic Name | Bromfenac Sodium |
| Dosage Form | Solution/ Drops |
| Route of Administration | OPHTHALMIC |
| Marketing Start Date | 2013-04-05 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203168 |
| Labeler Name | Bausch & Lomb Incorporated |
| Substance Name | BROMFENAC SODIUM |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 24208-602-03
1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) > 3 mL in 1 BOTTLE, DROPPER
| Marketing Start Date | 2013-04-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 24208-602-04 [24208060204]
Prolensa SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA203168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-04-30 |
NDC 24208-602-06 [24208060206]
Prolensa SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA203168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-04-05 |
NDC 24208-602-03 [24208060203]
Prolensa SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA203168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-04-05 |
NDC 24208-602-01 [24208060201]
Prolensa SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA203168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-04-05 |
| Marketing End Date | 2016-03-31 |
NDC 24208-602-02 [24208060202]
Prolensa SOLUTION/ DROPS
| Marketing Category | NDA |
| Application Number | NDA203168 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-10-21 |
| Marketing End Date | 2014-12-23 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BROMFENAC SODIUM | .7 mg/mL |
OpenFDA Data
| SPL SET ID: | 4e072537-f73c-4a96-a65f-e2805ce112d8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Cyclooxygenase Inhibitors [MoA]
- Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Anti-Inflammatory Agents
- Non-Steroidal [CS]
- Cyclooxygenase Inhibitors [MoA]
- Anti-Inflammatory Agents
- Non-Steroidal [CS]
- Nonsteroidal Anti-inflammatory Drug [EPC]
Medicade Reported Pricing
24208060203 PROLENSA 0.07% EYE DROPS
Pricing Unit: ML | Drug Type:
24208060201 PROLENSA 0.07% EYE DROPS
Pricing Unit: ML | Drug Type:
Trademark Results [Prolensa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROLENSA 85336395 4407493 Live/Registered |
BAUSCH & LOMB PHARMA HOLDINGS CORP. 2011-06-02 |
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