evoxac

Generic: cevimeline hydrochloride

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

Drug Facts

Product Profile

Brand Name evoxac
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 0713-0883
Product ID 0713-0883_e816e1db-d4e5-425f-e053-2995a90a27c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020989
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130883
Hyphenated Format 0713-0883

Supplemental Identifiers

RxCUI
261361 309140
UPC
0307130883016
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 evoxac (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 (0713-0883-01)
source: ndc

Packages (1)

0713-0883-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01)

Ingredients (1)

cevimeline hydrochloride (30 mg/1)

Linked Drug Pages (1)

Evoxac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e816e1db-d4e5-425f-e053-2995a90a27c5", "openfda": {"upc": ["0307130883016"], "unii": ["P81Q6V85NP"], "rxcui": ["261361", "309140"], "spl_set_id": ["dac32a9b-05b8-42c2-9a29-d885a9279456"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0883-01)", "package_ndc": "0713-0883-01", "marketing_start_date": "20220901"}], "brand_name": "Evoxac", "product_id": "0713-0883_e816e1db-d4e5-425f-e053-2995a90a27c5", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "0713-0883", "generic_name": "cevimeline hydrochloride", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Evoxac", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA020989", "marketing_category": "NDA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}