cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cevimeline hydrochloride 30 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0334
Product ID 0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091591
Listing Expiration 2026-12-31
Marketing Start 2013-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540334
Hyphenated Format 0054-0334

Supplemental Identifiers

RxCUI
309140
UPC
0300540334253
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 ANDA091591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0054-0334-25)
source: ndc

Packages (1)

0054-0334-25 100 CAPSULE in 1 BOTTLE (0054-0334-25)

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": "3cca3720-dca8-40cf-8de7-8f3444125ece", "openfda": {"upc": ["0300540334253"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["1167360c-7e0f-4619-9d1a-ad4ee56cab71"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0054-0334-25)", "package_ndc": "0054-0334-25", "marketing_start_date": "20130708"}], "brand_name": "Cevimeline Hydrochloride", "product_id": "0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "0054-0334", "generic_name": "Cevimeline Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cevimeline Hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA091591", "marketing_category": "ANDA", "marketing_start_date": "20130708", "listing_expiration_date": "20261231"}