NDC 43378-123

Zodryl DEC 40

Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride

Zodryl DEC 40 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: 43378-123_b51a9a1b-ddbe-47fc-bd22-d9e078dccb9b
• NDC: 43378-123
• Product Type: Human Otc Drug
• Proprietary Name: Zodryl DEC 40
• 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/4.5mL; mg/4.5mL; mg/4.5mL
• DEA Schedule: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 43378-123-04

118 mL in 1 BOTTLE, PLASTIC (43378-123-04)

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

NDC SPL Data Element Entries

NDC 43378-123-04 [43378012304]

Zodryl DEC 40 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	14.998 mg/4.5mL

OpenFDA Data

• SPL SET ID: 7d1e58cc-5306-4c97-9f74-e364d0b023e5
• Manufacturer:
  • CodaDose, Inc.
• UNII:
  • 6V9V2RYJ8N
  • GSL05Y1MN6
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1088965
  • 1088963
• UPC Code:
  • 0343378123040

NDC Crossover Matching brand name "Zodryl DEC 40" or generic name "Codeine Phosphate, Guaifenesin And Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
43378-123	Zodryl DEC 40	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
43378-124	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