NDC 0054-0334

Cevimeline Hydrochloride

Cevimeline Hydrochloride

Cevimeline Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Cevimeline Hydrochloride.

• Product ID: 0054-0334_3188899e-03aa-415a-b259-dc5e8c3aa0f7
• NDC: 0054-0334
• Product Type: Human Prescription Drug
• Proprietary Name: Cevimeline Hydrochloride
• Generic Name: Cevimeline Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2013-07-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091591
• Labeler Name: West-Ward Pharmaceuticals Corp.
• Substance Name: CEVIMELINE HYDROCHLORIDE
• Active Ingredient Strength: 30 mg/1
• Pharm Classes: Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0054-0334-25

100 CAPSULE in 1 BOTTLE (0054-0334-25)

• Marketing Start Date: 2013-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0334-25 [00054033425]

Cevimeline Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA091591
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-07-08

Drug Details

Active Ingredients

Ingredient	Strength
CEVIMELINE HYDROCHLORIDE	30 mg/1

OpenFDA Data

• SPL SET ID: 1167360c-7e0f-4619-9d1a-ad4ee56cab71
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • P81Q6V85NP
• RxNorm Concept Unique ID - RxCUI:
  • 309140
• UPC Code:
  • 0300540334253

Pharmacological Class

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

NDC Crossover Matching brand name "Cevimeline Hydrochloride" or generic name "Cevimeline Hydrochloride"

NDC	Brand Name	Generic Name
0054-0334	Cevimeline Hydrochloride	Cevimeline Hydrochloride
0713-0937	cevimeline hydrochloride	cevimeline hydrochloride
16571-657	Cevimeline Hydrochloride	Cevimeline Hydrochloride
40032-999	cevimeline hydrochloride	cevimeline hydrochloride
43386-999	cevimeline hydrochloride	cevimeline hydrochloride
0713-0883	Evoxac	cevimeline hydrochloride
63395-201	Evoxac	cevimeline hydrochloride