cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: novel laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cevimeline hydrochloride 30 mg/1

Manufacturer
Novel Laboratories, Inc.

Identifiers & Regulatory

Product NDC 40032-999
Product ID 40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204746
Listing Expiration 2026-12-31
Marketing Start 2016-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 40032999
Hyphenated Format 40032-999

Supplemental Identifiers

RxCUI
309140
UPC
0340032999010 0340032999058 0340032999034
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 ANDA204746 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (40032-999-01)
  • 30 CAPSULE in 1 BOTTLE (40032-999-03)
  • 500 CAPSULE in 1 BOTTLE (40032-999-05)
source: ndc

Packages (3)

40032-999-01 100 CAPSULE in 1 BOTTLE (40032-999-01) 40032-999-03 30 CAPSULE in 1 BOTTLE (40032-999-03) 40032-999-05 500 CAPSULE in 1 BOTTLE (40032-999-05)

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": "c42fae45-bbcf-40b6-911d-ebe3893f10ba", "openfda": {"upc": ["0340032999010", "0340032999058", "0340032999034"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["d7432a48-1142-431e-997f-8419dc724824"], "manufacturer_name": ["Novel Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (40032-999-01)", "package_ndc": "40032-999-01", "marketing_start_date": "20161230"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (40032-999-03)", "package_ndc": "40032-999-03", "marketing_start_date": "20161230"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (40032-999-05)", "package_ndc": "40032-999-05", "marketing_start_date": "20161230"}], "brand_name": "cevimeline hydrochloride", "product_id": "40032-999_c42fae45-bbcf-40b6-911d-ebe3893f10ba", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "40032-999", "generic_name": "cevimeline hydrochloride", "labeler_name": "Novel Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cevimeline hydrochloride", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA204746", "marketing_category": "ANDA", "marketing_start_date": "20161230", "listing_expiration_date": "20261231"}