NDC 43378-125

Zodryl DEC 60

Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride

Zodryl DEC 60 is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Codadose, Inc.. The primary component is Pseudoephedrine Hydrochloride; Codeine Phosphate; Guaifenesin.

• Product ID: 43378-125_980d54c0-8941-4180-8952-9ae39c5130b3
• NDC: 43378-125
• Product Type: Human Otc Drug
• Proprietary Name: Zodryl DEC 60
• Generic Name: Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2009-08-24
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: CodaDose, Inc.
• Substance Name: PSEUDOEPHEDRINE HYDROCHLORIDE; CODEINE PHOSPHATE; GUAIFENESIN
• Active Ingredient Strength: 30 mg/7.5mL; mg/7.5mL; mg/7.5mL
• DEA Schedule: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 43378-125-08

236 mL in 1 BOTTLE, PLASTIC (43378-125-08)

• Marketing Start Date: 2009-08-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43378-125-08 [43378012508]

Zodryl DEC 60 SUSPENSION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-08-24
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/7.5mL

OpenFDA Data

• SPL SET ID: 0e13fb71-49cc-4989-8a55-77d0d9d1eea0
• Manufacturer:
  • CodaDose, Inc.
• UNII:
  • 6V9V2RYJ8N
  • GSL05Y1MN6
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1088977
  • 1088975

NDC Crossover Matching brand name "Zodryl DEC 60" or generic name "Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
43378-125	Zodryl DEC 60	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-120	Zodryl DEC 25	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-121	Zodryl DEC 30	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-123	Zodryl DEC 40	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-124	Zodryl DEC 50	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-126	Zodryl DEC 80	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride