NDC 42192-612

Hydrocodone Bitartrate and Chlorpheniramine Maleate

Hydrocodone Bitartrate And Chlorpheniramine Maleate

Hydrocodone Bitartrate and Chlorpheniramine Maleate is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Acella Pharmaceuticals, Llc. The primary component is Hydrocodone Bitartrate; Chlorpheniramine Maleate.

• Product ID: 42192-612_5b24710c-b2d2-46bc-e053-2a91aa0a8535
• NDC: 42192-612
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Bitartrate and Chlorpheniramine Maleate
• Generic Name: Hydrocodone Bitartrate And Chlorpheniramine Maleate
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2017-06-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206891
• Labeler Name: Acella Pharmaceuticals, LLC
• Substance Name: HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 42192-612-16

480 mL in 1 BOTTLE (42192-612-16)

• Marketing Start Date: 2017-06-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42192-612-16 [42192061216]

Hydrocodone Bitartrate and Chlorpheniramine Maleate SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA206891
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-06-14

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	5 mg/5mL

OpenFDA Data

• SPL SET ID: 70a7ede0-885a-479a-9c64-dd9f19c2bbb0
• Manufacturer:
  • Acella Pharmaceuticals, LLC
• UNII:
  • V1Q0O9OJ9Z
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 1372265
• UPC Code:
  • 0342192612167

Pharmacological Class

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