NDC 13551-501
Primsol
Trimethoprim Hydrochloride
Primsol is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Fsc Laboratories, Inc. The primary component is Trimethoprim Hydrochloride.
| Product ID | 13551-501_0cc7d685-5819-4103-b667-375e23299dd8 |
| NDC | 13551-501 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Primsol |
| Generic Name | Trimethoprim Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2000-01-24 |
| Marketing Category | NDA / NDA |
| Application Number | NDA074973 |
| Labeler Name | FSC Laboratories, Inc |
| Substance Name | TRIMETHOPRIM HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/5mL |
| Pharm Classes | Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 13551-501-01
20 mL in 1 BOTTLE, PLASTIC (13551-501-01)
| Marketing Start Date | 2000-01-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13551-501-05 [13551050105]
Primsol SOLUTION
| Marketing Category | NDA |
| Application Number | NDA074973 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2000-01-24 |
| Inactivation Date | 2019-11-27 |
NDC 13551-501-01 [13551050101]
Primsol SOLUTION
| Marketing Category | NDA |
| Application Number | NDA074973 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2000-01-24 |
| Inactivation Date | 2019-11-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| TRIMETHOPRIM HYDROCHLORIDE | 50 mg/5mL |
OpenFDA Data
| SPL SET ID: | a06ea7d8-a884-4b62-a87f-c36d824f2aa4 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
- Dihydrofolate Reductase Inhibitors [MoA]
- Cytochrome P450 2C8 Inhibitors [MoA]
- Organic Cation Transporter 2 Inhibitors [MoA]
Medicade Reported Pricing
13551050105 PRIMSOL 50 MG/5 ML ORAL SOLN
Pricing Unit: ML | Drug Type:
NDC Crossover Matching brand name "Primsol" or generic name "Trimethoprim Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13551-501 | Primsol | trimethoprim hydrochloride |
| 71297-500 | PrimSol | TRIMETHOPRIM HYDROCHLORIDE |
Trademark Results [Primsol]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMSOL 77368235 3487990 Dead/Cancelled |
AYTU BIOSCIENCE, INC. 2008-01-10 |
 PRIMSOL 74541334 1941818 Dead/Cancelled |
FSC LABORATORIES, INC. 1994-06-23 |
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