NDC 0178-3482

Flowtuss

Hydrocodone Bitartrate, Guaifenesin

Flowtuss is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Mission Pharmacal Company. The primary component is Guaifenesin; Hydrocodone Bitartrate.

• Product ID: 0178-3482_71c4c9fd-e39f-7c68-e053-2a95a90a3f68
• NDC: 0178-3482
• Product Type: Human Prescription Drug
• Proprietary Name: Flowtuss
• Generic Name: Hydrocodone Bitartrate, Guaifenesin
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-18
• Marketing End Date: 2019-07-17
• Marketing Category: NDA / NDA
• Application Number: NDA022424
• Labeler Name: Mission Pharmacal Company
• Substance Name: GUAIFENESIN; HYDROCODONE BITARTRATE
• Active Ingredient Strength: 200 mg/5mL; mg/5mL
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 0178-3482-16

473 mL in 1 BOTTLE (0178-3482-16)

• Marketing Start Date: 2015-08-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0178-3482-16 [00178348216]

Flowtuss LIQUID

• Marketing Category: NDA
• Application Number: NDA022424
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-18
• Marketing End Date: 2019-07-17

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	200 mg/5mL

OpenFDA Data

• SPL SET ID: 1d0c2c03-ca11-30b1-e054-00144ff8d46c
• Manufacturer:
  • Mission Pharmacal Company
• UNII:
  • NO70W886KK
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 859383
  • 1650982

Pharmacological Class

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