NDC 45737-225

BioTPres

Dextromethorphan, Guaifenesin, Phenylephrine

BioTPres is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Advanced Generic Corporation. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 45737-225_7ae95891-2078-4569-bbcf-c96fadc2fc6f
• NDC: 45737-225
• Product Type: Human Otc Drug
• Proprietary Name: BioTPres
• Generic Name: Dextromethorphan, Guaifenesin, Phenylephrine
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2009-10-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Advanced Generic Corporation
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 15 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 45737-225-16

473 mL in 1 BOTTLE (45737-225-16)

• Marketing Start Date: 2009-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45737-225-16 [45737022516]

BioTPres LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-10-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL

OpenFDA Data

• SPL SET ID: 42eb824f-4de4-4c67-9932-6038a8dbea8c
• Manufacturer:
  • Advanced Generic Corporation
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ

NDC Crossover Matching brand name "BioTPres" or generic name "Dextromethorphan, Guaifenesin, Phenylephrine"

NDC	Brand Name	Generic Name
45737-225	BioTPres	Dextromethorphan, Guaifenesin, Phenylephrine
45737-227	BioTPres	Dextromethorphan, Guaifenesin, Phenylephrine
45737-246	Biobron	Dextromethorphan, Guaifenesin, Phenylephrine
45737-221	Biodesp	Dextromethorphan, Guaifenesin, Phenylephrine
45737-205	BioGtuss	Dextromethorphan, Guaifenesin, Phenylephrine
45737-242	BioGtuss	Dextromethorphan, Guaifenesin, Phenylephrine
11856-0031	Goyescas 7 Syrups Alcohol and Sugar Free	Dextromethorphan, Guaifenesin, Phenylephrine
11856-0001	Goyescas 7 Syrups Original	Dextromethorphan, Guaifenesin, Phenylephrine
11856-0016	Goyescas Broncovac 1	Dextromethorphan, Guaifenesin, Phenylephrine
11856-0025	Goyescas Broncovac 3	Dextromethorphan, Guaifenesin, Phenylephrine