Product NDC: | 16571-101 |
Proprietary Name: | Diclofenac Sodium |
Non Proprietary Name: | DICLOFENAC SODIUM |
Active Ingredient(s): | 3.5 mg/mL & nbsp; DICLOFENAC SODIUM |
Administration Route(s): | OPHTHALMIC |
Dosage Form(s): | SOLUTION/ DROPS |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16571-101 |
Labeler Name: | PACK Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078553 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080620 |
Package NDC: | 16571-101-25 |
Package Description: | 48 BOTTLE in 1 CASE (16571-101-25) > 2.5 mL in 1 BOTTLE |
NDC Code | 16571-101-25 |
Proprietary Name | Diclofenac Sodium |
Package Description | 48 BOTTLE in 1 CASE (16571-101-25) > 2.5 mL in 1 BOTTLE |
Product NDC | 16571-101 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | DICLOFENAC SODIUM |
Dosage Form Name | SOLUTION/ DROPS |
Route Name | OPHTHALMIC |
Start Marketing Date | 20080620 |
Marketing Category Name | ANDA |
Labeler Name | PACK Pharmaceuticals, LLC |
Substance Name | DICLOFENAC SODIUM |
Strength Number | 3.5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |