cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline hydrochloride
Generic Name cevimeline hydrochloride
Labeler cosette pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0937
Product ID 0713-0937_f183f958-57f5-ea10-e053-2995a90a5ead
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020989
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130937
Hyphenated Format 0713-0937

Supplemental Identifiers

RxCUI
309140
UPC
0307130937016
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 NDA020989 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)
source: ndc

Packages (1)

0713-0937-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)

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": "f183f958-57f5-ea10-e053-2995a90a5ead", "openfda": {"upc": ["0307130937016"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["efc2bb24-4dda-4781-bef5-fcd9abf082dd"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01)", "package_ndc": "0713-0937-01", "marketing_start_date": "20230103"}], "brand_name": "cevimeline hydrochloride", "product_id": "0713-0937_f183f958-57f5-ea10-e053-2995a90a5ead", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "0713-0937", "generic_name": "cevimeline hydrochloride", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cevimeline hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA020989", "marketing_category": "NDA", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}