50383-087 : Guaiatussin Ac Oral Liquid


NDC: 50383-087
Labeler: Hi-tech Pharmacal Co., Inc.
Product Type: Human OTC Drug
Drug Name:  Guaiatussin Ac
Dosage Form: Oral Liquid
Application #: part341
Rev. Date: 
CSA Schedule: CV (US) [1]


[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 50383-087-04: 118 ML IN 1 BOTTLE (50383‑087‑04)
  • 50383-087-07: 10 TRAY IN 1 CASE (50383‑087‑07) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE (50383‑087‑05)
  • 50383-087-12: 10 TRAY IN 1 CASE (50383‑087‑12) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 10 ML IN 1 CUP, UNIT‑DOSE (50383‑087‑10)
  • 50383-087-16: 473 ML IN 1 BOTTLE (50383‑087‑16)

Active Ingredients:

  • Codeine Phosphate
  • Guaifenesin

Dosage Strength:

  • 10 mg/5mL
  • 100 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50090-2651 Guaiatussin Ac Oral Liquid by A-s Medication Solutions

NDC QR Code

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NDC 50383-087 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.