NDC 69036-130

LORTUSS EX

Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride

LORTUSS EX is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Sallus Laboratories, Llc. The primary component is Codeine Phosphate; Guaifenesin; Pseudoephedrine Hydrochloride.

• Product ID: 69036-130_ec543c14-8427-4659-bcc0-3cdcd149ba81
• NDC: 69036-130
• Product Type: Human Otc Drug
• Proprietary Name: LORTUSS EX
• Generic Name: Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Sallus Laboratories, LLC
• Substance Name: CODEINE PHOSPHATE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/5mL; mg/5mL; mg/5mL
• DEA Schedule: CV
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69036-130-16

473 mL in 1 BOTTLE (69036-130-16)

• Marketing Start Date: 2014-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69036-130-16 [69036013016]

LORTUSS EX LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-06-01
• Marketing End Date: 2019-12-31
• Inactivation Date: 2019-11-27
• Reactivation Date: 2020-05-13

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	10 mg/5mL

OpenFDA Data

• SPL SET ID: 69ee642b-423c-4a68-8c16-cae09d3ef59d
• Manufacturer:
  • Sallus Laboratories, LLC
• UNII:
  • GSL05Y1MN6
  • 6V9V2RYJ8N
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1547607
  • 995983

Medicade Reported Pricing

69036013016 LORTUSS EX LIQUID

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "LORTUSS EX" or generic name "Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
69036-130	LORTUSS	Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride
60575-414	Tricode	Codeine Phosphate, Guaifenesin, Pseudoephedrine Hydrochloride