cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cevimeline hydrochloride
Generic Name cevimeline hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cevimeline hydrochloride 30 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-216
Product ID 33342-216_67215459-3dd7-4538-9938-7d7315607fb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206808
Listing Expiration 2027-12-31
Marketing Start 2024-10-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342216
Hyphenated Format 33342-216

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 ANDA206808 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (33342-216-11)
source: ndc

Packages (1)

33342-216-11 100 CAPSULE in 1 BOTTLE (33342-216-11)

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": "67215459-3dd7-4538-9938-7d7315607fb6", "openfda": {"unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["990887c1-11ce-4a73-83b4-0ffc5a900c85"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (33342-216-11)", "package_ndc": "33342-216-11", "marketing_start_date": "20241020"}], "brand_name": "Cevimeline Hydrochloride", "product_id": "33342-216_67215459-3dd7-4538-9938-7d7315607fb6", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "33342-216", "generic_name": "Cevimeline Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cevimeline Hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA206808", "marketing_category": "ANDA", "marketing_start_date": "20241020", "listing_expiration_date": "20271231"}