NDC 69315-248

CODEINE GUAIFENESIN

Codeine Phosphate, Guaifenesin

CODEINE GUAIFENESIN is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Codeine Phosphate; Guaifenesin.

• Product ID: 69315-248_4387821a-24d9-497c-bc91-b298e9e934d7
• NDC: 69315-248
• Product Type: Human Otc Drug
• Proprietary Name: CODEINE GUAIFENESIN
• Generic Name: Codeine Phosphate, Guaifenesin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2019-12-19
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Leading Pharma, 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 69315-248-12

120 mL in 1 BOTTLE (69315-248-12)

• Marketing Start Date: 2019-12-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69315-248-48 [69315024848]

CODEINE GUAIFENESIN SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-19

NDC 69315-248-12 [69315024812]

CODEINE GUAIFENESIN SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-12-19

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	10 mg/5mL

NDC Crossover Matching brand name "CODEINE GUAIFENESIN" or generic name "Codeine Phosphate, Guaifenesin"

NDC	Brand Name	Generic Name
68788-7921	CODEINE GUAIFENESIN	CODEINE PHOSPHATE, GUAIFENESIN
69315-248	CODEINE GUAIFENESIN	CODEINE PHOSPHATE, GUAIFENESIN
60575-616	Codar	Codeine Phosphate, Guaifenesin
12830-717	M-CLEAR	Codeine Phosphate, Guaifenesin