42794-004 : Protriptyline Hydrochloride 5 mg Oral Tablet, Film Coated


NDC: 42794-004
Labeler: Sigmapharm Laboratories, LLC
Product Type: Human Prescription Drug
Drug Name:  Protriptyline Hydrochloride
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA090462
Rev. Date: 


Appearance:


Markings: 4
Shapes:  Round
Colors:  Orange
Size (mm): 6
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.

4: (64980-158) Protriptyline Hydrochloride 5 mg Oral Tablet, Film Coated by Sigmapharm Laboratories, LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 42794-004-02: 100 TABLET, FILM COATED IN 1 BOTTLE (42794‑004‑02)

Active Ingredients:

  • Protriptyline Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Anhydrous Lactose
  • Crospovidone
  • Anhydrous Dibasic Calcium Phosphate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide
  • Fd&c Yellow No. 6 /

Pharmaceutical Classes:

  • Tricyclic Antidepressant [EPC]

Related Products:

Based on records with the same trade name.
  • 42794-007 Protriptyline Hydrochloride 10 mg Oral Tablet, Film Coated by Sigmapharm Laboratories, LLC
  • 0054-0210 Protriptyline Hydrochloride 5 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0211 Protriptyline Hydrochloride 10 mg Oral Tablet by Roxane Laboratories, Inc
  • 0555-0594 Protriptyline Hydrochloride 10 mg Oral Tablet by Barr Laboratories Inc.
  • 0555-0595 Protriptyline Hydrochloride 5 mg Oral Tablet by Barr Laboratories Inc.
  • 42806-096 Protriptyline Hydrochloride 5 mg Oral Tablet by Epic Pharma, LLC
  • 42806-097 Protriptyline Hydrochloride 10 mg Oral Tablet by Epic Pharma, LLC
  • 50383-959 Protriptyline Hydrochloride 5 mg by Hi-tech Pharmacal Co., Inc.
  • 50383-960 Protriptyline Hydrochloride 10 mg by Hi-tech Pharmacal Co., Inc.
  • 63629-8346 Protriptyline Hydrochloride 10 mg Oral Tablet by Bryant Ranch Prepack
  • 64980-158 Protriptyline Hydrochloride 5 mg Oral Tablet by Rising Pharmaceuticals, Inc
  • 64980-159 Protriptyline Hydrochloride 10 mg Oral Tablet by Rising Pharmaceuticals, Inc

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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.