NDC 43378-120

Zodryl DEC 25

Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride

Zodryl DEC 25 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: 43378-120_fa37ced4-619b-4514-9d32-ae50a6572427
• NDC: 43378-120
• Product Type: Human Otc Drug
• Proprietary Name: Zodryl DEC 25
• 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: 15 mg/3mL; mg/3mL; mg/3mL
• DEA Schedule: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 43378-120-04

118 mL in 1 BOTTLE, PLASTIC (43378-120-04)

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

NDC SPL Data Element Entries

NDC 43378-120-04 [43378012004]

Zodryl DEC 25 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	15 mg/3mL

OpenFDA Data

• SPL SET ID: 7b0051b0-1ae1-4eb5-9328-75f7b506f7d4
• Manufacturer:
  • CodaDose, Inc.
• UNII:
  • 6V9V2RYJ8N
  • GSL05Y1MN6
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1089027
  • 1089025
• UPC Code:
  • 0343378120049

NDC Crossover Matching brand name "Zodryl DEC 25" or generic name "Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
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
43378-125	Zodryl DEC 60	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
43378-126	Zodryl DEC 80	codeine phosphate, guaifenesin and pseudoephedrine hydrochloride