NDC 52083-648

DESGEN DM Tabs

Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride

DESGEN DM Tabs is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Pseudoephedrine Hydrochloride.

• Product ID: 52083-648_d51e9f91-e44f-4c24-9b34-127010d0299d
• NDC: 52083-648
• Product Type: Human Otc Drug
• Proprietary Name: DESGEN DM Tabs
• Generic Name: Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-26
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: KRAMER NOVIS
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1
• Pharm Classes: Adrenergic alpha-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-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 52083-648-10

100 TABLET in 1 BOTTLE, PLASTIC (52083-648-10)

• Marketing Start Date: 2015-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-648-10 [52083064810]

DESGEN DM Tabs TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-26

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 74a2937d-12d5-4c0b-b237-074b4d7c30b1
• Manufacturer:
  • KRAMER NOVIS
• UNII:
  • 6V9V2RYJ8N
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1114896

NDC Crossover Matching brand name "DESGEN DM Tabs" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
52083-648	DESGEN DM Tabs	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
29978-606	CAPMIST	Dextromethorphan Hydrobromide, Guaifenesin, Pseudoephedrine Hydrochloride
52083-628	PECGEN PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
58238-228	TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
58238-230	TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE