NDC 52083-660

Sorbugen

Dextromethorphan Hydrobromide, Glycerol Guaiacolate

Sorbugen is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 52083-660_13682546-cf2e-493d-a0fa-12777b7849fa
• NDC: 52083-660
• Product Type: Human Otc Drug
• Proprietary Name: Sorbugen
• Generic Name: Dextromethorphan Hydrobromide, Glycerol Guaiacolate
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Kramer Novis
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 15 mg/7.5mL; mg/7.5mL
• Pharm Classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 52083-660-16

480 mL in 1 BOTTLE (52083-660-16)

• Marketing Start Date: 2014-10-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-660-16 [52083066016]

Sorbugen SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-10-08

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/7.5mL

OpenFDA Data

• SPL SET ID: a8f2a2d7-0360-45a8-9635-c852f4a7d7ba
• Manufacturer:
  • Kramer Novis
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 996520
• UPC Code:
  • 0352083660160