NDC 71248-003

DiThol

Diclofenac Sodium/menthol

DiThol is a Kit in the Human Prescription Drug category. It is labeled and distributed by Fortus Pharma, Llc. The primary component is .

• Product ID: 71248-003_01006c90-2b10-4d5a-8f40-38b5a15c334d
• NDC: 71248-003
• Product Type: Human Prescription Drug
• Proprietary Name: DiThol
• Generic Name: Diclofenac Sodium/menthol
• Dosage Form: Kit
• Marketing Start Date: 2017-12-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203818
• Labeler Name: Fortus Pharma, LLC
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 71248-003-03

1 KIT in 1 KIT (71248-003-03) * 89 mL in 1 BOTTLE * 150 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2017-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71248-003-03 [71248000303]

DiThol KIT

• Marketing Category: ANDA
• Application Number: ANDA203818
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-12-22
• Marketing End Date: 2019-05-16

Drug Details

OpenFDA Data

• SPL SET ID: 527f16a6-d735-4603-86f8-319aea59caec
• Manufacturer:
  • Fortus Pharma, LLC
• RxNorm Concept Unique ID - RxCUI:
  • 857700
  • 1600976