40032-999 : Cevimeline Hydrochloride 30 mg Oral Capsule

Labeler: Novel Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Cevimeline Hydrochloride
Dosage Form: Oral Capsule
Application #: ANDA204746
Rev. Date: 


Markings: NL999;30mg
Shapes:  Capsule
Colors:  Brown
Size (mm): 16
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:

  • 40032-999-01: 100 CAPSULE IN 1 BOTTLE (40032‑999‑01)
  • 40032-999-03: 30 CAPSULE IN 1 BOTTLE (40032‑999‑03)
  • 40032-999-05: 500 CAPSULE IN 1 BOTTLE (40032‑999‑05)

Active Ingredients:

  • Cevimeline Hydrochloride

Dosage Strength:

  • 30 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Hydroxypropyl Cellulose (Type E)
  • Magnesium Stearate
  • D&c Yellow No. 10
  • Fd&c Red No. 40
  • Fd&c Yellow No. 6
  • Titanium Dioxide
  • Gelatin
  • Shellac
  • Isopropyl Alcohol
  • Butyl Alcohol
  • Propylene Glycol
  • Ferrosoferric Oxide
  • Ammonia

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0054-0334 Cevimeline (As Cevimeline Hydrochloride) 30 mg Oral Capsule by Roxane Laboratories, Inc.
  • 16571-657 Cevimeline Hydrochloride 30 mg Oral Capsule by Pack Pharmaceuticals, LLC
  • 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
  • 60505-3145 Cevimeline (As Cevimeline Hydrochloride) 30 mg Oral Capsule by Apotex Corp.
  • 69189-0399 Cevimeline Hydrochloride 30 mg Oral Capsule by Avera Mckennan Hospital


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