54868-6087 : Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride (Fexofenadine Hydrochloride 60 mg / Pseudoephedrine Hydrochloride 120 mg)


NDC: 54868-6087
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA020786
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.

Appearance:


Markings: 93;T13
Shapes:  Oval
Colors:  White
Size (mm): 19
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54868-6087-0: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (54868‑6087‑0)
  • 54868-6087-1: 10 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (54868‑6087‑1)
  • 54868-6087-2: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (54868‑6087‑2)

Active Ingredients:

  • Fexofenadine Hydrochloride
  • Pseudoephedrine Hydrochloride

Dosage Strength:

  • 60 mg
  • 120 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Magnesium Stearate
  • Carnauba Wax
  • Stearic Acid
  • Silicon Dioxide
  • Hypromellose
  • Polyethylene Glycol

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0363-0044 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Walgreens Company
  • 0363-0094 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Walgreen Co.
  • 0363-2110 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Walgreens
  • 0536-1384 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Rugby Laboratories
  • 0555-0725 Fexofenadine Hydrochloride 60 mg / Pseudoephedrine Hydrochloride 120 mg 12 Hr Extended Release Tablet by Barr Laboratories Inc.
  • 11822-0021 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Rite Aid Corporation
  • 21695-820 Fexofenadine Hydrochloride 60 mg / Pseudoephedrine Hydrochloride 120 mg 12 Hr Extended Release Tablet by Rebel Distributors Corp
  • 30142-059 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Kroger Company
  • 30142-097 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Kroger Company
  • 37808-999 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by H E B
  • 41415-995 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Publix Super Markets, Inc
  • 46122-452 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Amerisource Bergen
  • 46122-694 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Amerisource Bergen
  • 47335-724 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Sun Pharma Global Fze
  • 51316-007 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Cvs Pharmacy, Inc.
  • 51316-015 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Extended Release by Cvs Health Corp
  • 51660-037 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Ohm Laboratories Inc.
  • 56062-999 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Publix Super Markets Inc
  • 58602-807 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Aurohealth LLC
  • 62011-0376 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Oral Tablet, Film Coated, Extended Release by Mckesson Corporation
  • More related products ...

NDC 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.