NDC 28595-905

Duravent PE

Guaifenesin And Phenylephrine Hydrochloride

Duravent PE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Allegis Pharmaceuticals, Llc. The primary component is Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 28595-905_a8aa7148-a219-4c68-895c-b3753d730526
• NDC: 28595-905
• Product Type: Human Otc Drug
• Proprietary Name: Duravent PE
• Generic Name: Guaifenesin And Phenylephrine Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-02-27
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Allegis Pharmaceuticals, LLC
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 395 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 28595-905-60

60 TABLET in 1 BOTTLE (28595-905-60)

• Marketing Start Date: 2014-02-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 28595-905-60 [28595090560]

Duravent PE TABLET

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-02-27
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	395 mg/1

OpenFDA Data

• SPL SET ID: fa424a60-0eca-4d51-b82d-d267bf12a082
• Manufacturer:
  • Allegis Pharmaceuticals, LLC
• UNII:
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1490021
  • 1490015

NDC Crossover Matching brand name "Duravent PE" or generic name "Guaifenesin And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
28595-905	Duravent PE	GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE
58602-108	AuroMucus - Childrens Stuffy Nose and Cold	Guaifenesin and Phenylephrine hydrochloride
58602-152	AuroMucus - Childrens Stuffy Nose and Cold	Guaifenesin and Phenylephrine hydrochloride
49523-501	Baczol Expectorant	GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE
63824-284	Childrens Mucinex Stuffy Nose and Cold	Guaifenesin and Phenylephrine Hydrochloride
59779-454	CVS - Childrens Stuffy Nose and Cold	Guaifenesin and Phenylephrine hydrochloride
58605-314	Maxi-Tuss PE Jr	GUAIFENESIN and Phenylephrine Hydrochloride
58605-315	Maxi-Tuss PE Max	GUAIFENESIN and Phenylephrine Hydrochloride
58605-422	Maxiphen	GUAIFENESIN and Phenylephrine Hydrochloride
63824-951	Mucinex Childrens	Guaifenesin and Phenylephrine Hydrochloride
64543-044	Rescon GG	Guaifenesin and Phenylephrine Hydrochloride