cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline hydrochloride
Generic Name cevimeline hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-657
Product ID 16571-657_640e50a9-48ba-45e3-a3cb-c14bb313cc4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203775
Listing Expiration 2026-12-31
Marketing Start 2014-06-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571657
Hyphenated Format 16571-657

Supplemental Identifiers

RxCUI
309140
UPC
0316571657100
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 ANDA203775 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (16571-657-10)
source: ndc

Packages (1)

16571-657-10 100 CAPSULE in 1 BOTTLE (16571-657-10)

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": "640e50a9-48ba-45e3-a3cb-c14bb313cc4f", "openfda": {"upc": ["0316571657100"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["d4bd942a-1339-40c5-8fd4-850da5a69635"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (16571-657-10)", "package_ndc": "16571-657-10", "marketing_start_date": "20140617"}], "brand_name": "Cevimeline Hydrochloride", "product_id": "16571-657_640e50a9-48ba-45e3-a3cb-c14bb313cc4f", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "16571-657", "generic_name": "Cevimeline Hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cevimeline Hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA203775", "marketing_category": "ANDA", "marketing_start_date": "20140617", "listing_expiration_date": "20261231"}