cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline hydrochloride
Generic Name cevimeline hydrochloride
Labeler advagen pharma ltd
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-118
Product ID 72888-118_473cb6cb-6b57-127c-e063-6394a90adbe8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216682
Listing Expiration 2026-12-31
Marketing Start 2023-04-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888118
Hyphenated Format 72888-118

Supplemental Identifiers

RxCUI
309140
UPC
0372888118307 0372888118055 0372888118000 0372888118017
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 hydrochloride (source: ndc)
Generic Name cevimeline hydrochloride (source: ndc)
Application Number ANDA216682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 1000 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-00)
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-01)
  • 500 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-05)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-30)
source: ndc

Packages (4)

72888-118-00 1000 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-00) 72888-118-01 100 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-01) 72888-118-05 500 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-05) 72888-118-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-30)

Ingredients (1)

cevimeline hydrochloride (30 mg/1)

Linked Drug Pages (1)

CEVIMELINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "473cb6cb-6b57-127c-e063-6394a90adbe8", "openfda": {"upc": ["0372888118307", "0372888118055", "0372888118000", "0372888118017"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-00)", "package_ndc": "72888-118-00", "marketing_start_date": "20230503"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-01)", "package_ndc": "72888-118-01", "marketing_start_date": "20230503"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-05)", "package_ndc": "72888-118-05", "marketing_start_date": "20230503"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72888-118-30)", "package_ndc": "72888-118-30", "marketing_start_date": "20230503"}], "brand_name": "CEVIMELINE HYDROCHLORIDE", "product_id": "72888-118_473cb6cb-6b57-127c-e063-6394a90adbe8", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "72888-118", "generic_name": "CEVIMELINE HYDROCHLORIDE", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEVIMELINE HYDROCHLORIDE", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA216682", "marketing_category": "ANDA", "marketing_start_date": "20230406", "listing_expiration_date": "20261231"}