0054-0334 : Cevimeline (As Cevimeline Hydrochloride) 30 mg Oral Capsule


NDC: 0054-0334
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Cevimeline Hydrochloride
Dosage Form: Oral Capsule
Application #: ANDA091591
Rev. Date: 


Appearance:


Markings: 54;190
Shapes:  Capsule
Colors:  White
Size (mm): 3
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.

54 190: (0054-0334) Cevimeline (As Cevimeline Hydrochloride) 30 mg Oral Capsule by Roxane Laboratories, Inc.
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:

  • 0054-0334-25: 100 CAPSULE IN 1 BOTTLE (0054‑0334‑25)

Active Ingredients:

  • Cevimeline Hydrochloride

Dosage Strength:

  • 30 mg

Inactive Ingredients:

  • Glycerin
  • Hydroxypropyl Cellulose (Type H)
  • Ferric Oxide Red
  • Lactose Monohydrate
  • Magnesium Stearate
  • Water
  • Sodium Lauryl Sulfate
  • Titanium Dioxide

Pharmaceutical Classes:

  • Cholinergic Muscarinic Agonists [MoA]
  • Cholinergic Receptor Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0713-0937 Cevimeline Hydrochloride 30 mg Oral Capsule by Cosette Pharmaceuticals, Inc.
  • 16571-657 Cevimeline Hydrochloride 30 mg Oral Capsule by Pack Pharmaceuticals, LLC
  • 40032-999 Cevimeline Hydrochloride 30 mg Oral Capsule by Novel Laboratories, Inc.
  • 43386-999 Cevimeline Hydrochloride 30 mg Oral Capsule by Lupin Pharmaceuticals, Inc.
  • 52682-500 Cevimeline Hydrochloride 30 mg Oral Capsule by Ingenus Pharmaceuticals Nj, LLC
  • 59651-422 Cevimeline Hydrochloride 30 mg Oral Capsule by Aurobindo Pharma Limited
  • 60505-3145 Cevimeline (As Cevimeline Hydrochloride) 30 mg Oral Capsule by Apotex Corp.
  • 63629-9863 Cevimeline Hydrochloride 30 mg Oral Capsule by Bryant Ranch Prepack
  • 69189-0399 Cevimeline Hydrochloride 30 mg Oral Capsule by Avera Mckennan Hospital
  • 71335-2264 Cevimeline Hydrochloride 30 mg Oral Capsule by Bryant Ranch Prepack
  • 72888-118 Cevimeline Hydrochloride 30 mg Oral Capsule by Advagen Pharma Ltd

NDC QR Code

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NDC 0054-0334 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.