NDC 58657-500

Codeine-Guaifenesin

Codeine Phosphate And Guaifenesin

Codeine-Guaifenesin is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Method Pharmaceuticals, Llc. The primary component is Codeine Phosphate; Guaifenesin.

• Product ID: 58657-500_9e5039e8-cf10-20da-e053-2a95a90ad88e
• NDC: 58657-500
• Product Type: Human Otc Drug
• Proprietary Name: Codeine-Guaifenesin
• Generic Name: Codeine Phosphate And Guaifenesin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Method Pharmaceuticals, LLC
• Substance Name: CODEINE PHOSPHATE; GUAIFENESIN
• Active Ingredient Strength: 10 mg/5mL; mg/5mL
• DEA Schedule: CV
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58657-500-04

120 mL in 1 BOTTLE (58657-500-04)

• Marketing Start Date: 2014-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58657-500-16 [58657050016]

Codeine-Guaifenesin SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-04-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-11

NDC 58657-500-04 [58657050004]

Codeine-Guaifenesin SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-04-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-11

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	10 mg/5mL

OpenFDA Data

• SPL SET ID: fe126254-6ee6-48c3-965c-96e4276a5314
• Manufacturer:
  • Method Pharmaceuticals, LLC
• UNII:
  • GSL05Y1MN6
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 995868
• UPC Code:
  • 0358657500160

Medicade Reported Pricing

58657050016 CODEINE-GUAIFEN 10-100 MG/5 ML

Pricing Unit: ML | Drug Type:

58657050004 CODEINE-GUAIFEN 10-100 MG/5 ML

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Codeine-Guaifenesin" or generic name "Codeine Phosphate And Guaifenesin"

NDC	Brand Name	Generic Name
17856-0273	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
17856-0500	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
55700-741	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
58657-500	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
68071-2472	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
68071-5173	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
68788-7235	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
69367-272	Codeine-Guaifenesin	Codeine Phosphate and Guaifenesin
0603-1075	Cheratussin AC	codeine phosphate and guaifenesin
21695-421	Cheratussin AC	codeine phosphate and guaifenesin
50090-0423	Cheratussin AC	codeine phosphate and guaifenesin
53002-3190	Cheratussin AC	codeine phosphate and guaifenesin
68788-9066	Cheratussin AC	codeine phosphate and guaifenesin
17856-0208	Codeine Phosphate and Guaifenesin	codeine phosphate and guaifenesin
54932-208	Codeine Phosphate and Guaifenesin	codeine phosphate and guaifenesin
57963-103	G Tussin AC	CODEINE PHOSPHATE and GUAIFENESIN
0682-0475	MAR-COF CG	CODEINE PHOSPHATE and GUAIFENESIN
58605-313	Maxi-Tuss AC	CODEINE PHOSPHATE and GUAIFENESIN
50090-3170	Virtussin A/C	Codeine phosphate and Guaifenesin
50436-2520	Virtussin A/C	Codeine phosphate and Guaifenesin
50090-5398	Virtussin AC	Codeine phosphate and Guaifenesin
63629-2486	Virtussin AC	Codeine phosphate and Guaifenesin
63629-2487	Virtussin AC	Codeine phosphate and Guaifenesin
69543-252	Virtussin AC	Codeine phosphate and Guaifenesin
69543-251	VIRTUSSIN AC W/ALC	Codeine phosphate and guaifenesin