cevimeline

Generic: cevimeline

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline
Generic Name cevimeline
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-479
Product ID 63304-479_558c3230-3788-4ef0-a5b5-3c06870317a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020989
Marketing Start 2016-03-10
Marketing End 2027-04-30

Pharmacologic Class

Classes
cholinergic muscarinic agonists [moa] cholinergic receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304479
Hyphenated Format 63304-479

Supplemental Identifiers

RxCUI
309140
UNII
P81Q6V85NP

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cevimeline (source: ndc)
Generic Name cevimeline (source: ndc)
Application Number NDA020989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (63304-479-01)
source: ndc

Packages (1)

63304-479-01 100 CAPSULE in 1 BOTTLE (63304-479-01)

Ingredients (1)

cevimeline hydrochloride (30 mg/1)

Linked Drug Pages (1)

Cevimeline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "558c3230-3788-4ef0-a5b5-3c06870317a9", "openfda": {"unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["773a19e8-4c3e-4414-99a6-aea98c9790ee"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63304-479-01)", "package_ndc": "63304-479-01", "marketing_end_date": "20270430", "marketing_start_date": "20160310"}], "brand_name": "Cevimeline", "product_id": "63304-479_558c3230-3788-4ef0-a5b5-3c06870317a9", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "63304-479", "generic_name": "Cevimeline", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cevimeline", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA020989", "marketing_category": "NDA", "marketing_end_date": "20270430", "marketing_start_date": "20160310"}