NDC 52083-653

PRESGEN PEDIATRIC

Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide

PRESGEN PEDIATRIC 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; Phenylephrine Hydrochloride.

• Product ID: 52083-653_045188e8-2c41-476a-b86f-75cf57bc2101
• NDC: 52083-653
• Product Type: Human Otc Drug
• Proprietary Name: PRESGEN PEDIATRIC
• Generic Name: Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2011-03-24
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: KRAMER NOVIS
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL; mg/5mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 52083-653-16

480 mL in 1 BOTTLE (52083-653-16)

• Marketing Start Date: 2011-03-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-653-16 [52083065316]

PRESGEN PEDIATRIC SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-24

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	75 mg/5mL

OpenFDA Data

• SPL SET ID: 12fb91e5-6059-4b3a-a2de-762aa51a25b7
• Manufacturer:
  • KRAMER NOVIS
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1119541

NDC Crossover Matching brand name "PRESGEN PEDIATRIC" or generic name "Guaifenesin, Phenylephrine Hcl,dextromethorphan Hydrobromide"

NDC	Brand Name	Generic Name
52083-653	PRESGEN PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE
52083-232	TUSSI PRES PEDIATRIC	GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE