NDC 71297-500

PrimSol

Trimethoprim Hydrochloride

PrimSol is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Allegis Holdings, Llc. The primary component is Trimethoprim Hydrochloride.

• Product ID: 71297-500_9342b462-0983-4c9f-9b0e-e998b1061b31
• NDC: 71297-500
• Product Type: Human Prescription Drug
• Proprietary Name: PrimSol
• Generic Name: Trimethoprim Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-04
• Marketing Category: NDA / NDA
• Application Number: NDA074973
• Labeler Name: Allegis Holdings, LLC
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71297-500-16

473 mL in 1 BOTTLE, PLASTIC (71297-500-16)

• Marketing Start Date: 2017-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71297-500-20 [71297050020]

PrimSol SOLUTION

• Marketing Category: NDA
• Application Number: NDA074973
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-04

NDC 71297-500-16 [71297050016]

PrimSol SOLUTION

• Marketing Category: NDA
• Application Number: NDA074973
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-05-04

Drug Details

Active Ingredients

Ingredient	Strength
TRIMETHOPRIM HYDROCHLORIDE	50 mg/5mL

OpenFDA Data

• SPL SET ID: f40d6d72-31c3-4ef8-b86c-0230e06a9383
• Manufacturer:
  • Allegis Holdings, LLC
• UNII:
  • 9XE000OU9B
• RxNorm Concept Unique ID - RxCUI:
  • 261353
  • 562707

Pharmacological Class

• Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
• Dihydrofolate Reductase Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]
• Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
• Dihydrofolate Reductase Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Organic Cation Transporter 2 Inhibitors [MoA]

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