cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline hydrochloride
Generic Name cevimeline hydrochloride
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-422
Product ID 59651-422_d08d8aa5-76a4-417a-a308-7d195865522f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215056
Listing Expiration 2026-12-31
Marketing Start 2023-04-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651422
Hyphenated Format 59651-422

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 hydrochloride (source: ndc)
Generic Name cevimeline hydrochloride (source: ndc)
Application Number ANDA215056 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-422-01)
  • 500 CAPSULE in 1 BOTTLE (59651-422-05)
source: ndc

Packages (2)

59651-422-01 100 CAPSULE in 1 BOTTLE (59651-422-01) 59651-422-05 500 CAPSULE in 1 BOTTLE (59651-422-05)

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": "d08d8aa5-76a4-417a-a308-7d195865522f", "openfda": {"unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["d08d8aa5-76a4-417a-a308-7d195865522f"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-422-01)", "package_ndc": "59651-422-01", "marketing_start_date": "20230418"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (59651-422-05)", "package_ndc": "59651-422-05", "marketing_start_date": "20230418"}], "brand_name": "Cevimeline Hydrochloride", "product_id": "59651-422_d08d8aa5-76a4-417a-a308-7d195865522f", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "59651-422", "generic_name": "Cevimeline Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cevimeline Hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA215056", "marketing_category": "ANDA", "marketing_start_date": "20230418", "listing_expiration_date": "20261231"}