cevimeline

Generic: cevimeline hydrochloride

Labeler: bionpharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline
Generic Name cevimeline hydrochloride
Labeler bionpharma inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Bionpharma Inc

Identifiers & Regulatory

Product NDC 69452-316
Product ID 69452-316_10e26216-a6d9-ab89-e063-6294a90a298c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218290
Listing Expiration 2026-12-31
Marketing Start 2024-01-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452316
Hyphenated Format 69452-316

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 hydrochloride (source: ndc)
Application Number ANDA218290 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69452-316-20)
source: ndc

Packages (1)

69452-316-20 100 CAPSULE in 1 BOTTLE (69452-316-20)

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": "10e26216-a6d9-ab89-e063-6294a90a298c", "openfda": {"unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["0f15cb50-5917-c928-e063-6294a90ab284"], "manufacturer_name": ["Bionpharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69452-316-20)", "package_ndc": "69452-316-20", "marketing_start_date": "20240117"}], "brand_name": "CEVIMELINE", "product_id": "69452-316_10e26216-a6d9-ab89-e063-6294a90a298c", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "69452-316", "generic_name": "CEVIMELINE HYDROCHLORIDE", "labeler_name": "Bionpharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEVIMELINE", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA218290", "marketing_category": "ANDA", "marketing_start_date": "20240117", "listing_expiration_date": "20261231"}