NDC 69101-620

Hydrocodone Bitartrate and Guaifenesin

Hydrocodone Bitartrate And Guaifenesin

Hydrocodone Bitartrate and Guaifenesin is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Burke Therapeutics. The primary component is Hydrocodone Bitartrate; Guaifenesin.

• Product ID: 69101-620_7c4a6dde-28e0-0cee-e053-2991aa0abfec
• NDC: 69101-620
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Bitartrate and Guaifenesin
• Generic Name: Hydrocodone Bitartrate And Guaifenesin
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA205474
• Labeler Name: Burke Therapeutics
• Substance Name: HYDROCODONE BITARTRATE; GUAIFENESIN
• Active Ingredient Strength: 3 mg/5mL; mg/5mL
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69101-620-01

118 mL in 1 BOTTLE (69101-620-01)

• Marketing Start Date: 2018-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69101-620-01 [69101062001]

Hydrocodone Bitartrate and Guaifenesin SOLUTION

• Marketing Category: NDA
• Application Number: NDA205474
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-02
• Marketing End Date: 2019-06-12

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	2.5 mg/5mL

OpenFDA Data

• SPL SET ID: b5686dd1-626e-4599-8305-c99cf6c15bea
• Manufacturer:
  • Burke Therapeutics
• UNII:
  • 495W7451VQ
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 859383
• UPC Code:
  • 0369101620013

Pharmacological Class

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

NDC Crossover Matching brand name "Hydrocodone Bitartrate and Guaifenesin" or generic name "Hydrocodone Bitartrate And Guaifenesin"

NDC	Brand Name	Generic Name
69101-620	Hydrocodone Bitartrate and Guaifenesin	Hydrocodone Bitartrate and Guaifenesin
58716-433	OBREDON	Hydrocodone Bitartrate and Guaifenesin