NDC 0722-7184

CODEINE AND CHLORPHENIRAMINE MALEATE ER

Codeine And Chlorpheniramine Maleate Er

CODEINE AND CHLORPHENIRAMINE MALEATE ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nexgen Pharma, Inc.. The primary component is Codeine Phosphate; Chlorpheniramine Maleate.

• Product ID: 0722-7184_6feb059d-5153-42a5-9306-6b05429ca86d
• NDC: 0722-7184
• Product Type: Human Prescription Drug
• Proprietary Name: CODEINE AND CHLORPHENIRAMINE MALEATE ER
• Generic Name: Codeine And Chlorpheniramine Maleate Er
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA206323
• Labeler Name: Nexgen Pharma, Inc.
• Substance Name: CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 54 mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 0722-7184-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0722-7184-01)

• Marketing Start Date: 2015-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0722-7184-01 [00722718401]

CODEINE AND CHLORPHENIRAMINE MALEATE ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA206323
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	54.3 mg/1

OpenFDA Data

• SPL SET ID: f3114cff-d638-4562-9e11-88130677363c
• Manufacturer:
  • Nexgen Pharma, Inc.
• UNII:
  • GSL05Y1MN6
  • V1Q0O9OJ9Z
• RxNorm Concept Unique ID - RxCUI:
  • 1664543
• UPC Code:
  • 0307226670018

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]