cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cevimeline hydrochloride 30 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-999
Product ID 43386-999_7e108db5-5292-4f2e-9d10-e15319503898
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 43386999
Hyphenated Format 43386-999

Supplemental Identifiers

RxCUI
309140
UPC
0343386999057
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
  • HOW SUPPLIED Cevimeline Hydrochloride Capsules are available as hard gelatin capsule with tan opaque cap and tan opaque body imprinted with "NL 999" on the cap and "30 mg" on the body with black ink, filled with white to off white granular powder. It is supplied in: Child-resistant bottles of 30 Capsules (NDC 43386-999-03) Child-resistant bottles of 100 Capsules (NDC 43386-999-01) Bottles of 500 Capsules (NDC 43386-999-05) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP/NF. Rx Only Manufactured by: Novel Laboratories, Inc . Somerset, NJ 08873 Manufactured For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Iss. 02/2019 PI9990000201
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Labels 30 Count 100 Count 500 Count 30 count 100 count 500 count
source: label

Packages (0)

No package records.

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": "7e108db5-5292-4f2e-9d10-e15319503898", "openfda": {"upc": ["0343386999057"], "unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["0fbcf1a7-5b8b-42fb-b764-4b529e7d1a99"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "cevimeline hydrochloride", "product_id": "43386-999_7e108db5-5292-4f2e-9d10-e15319503898", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "43386-999", "generic_name": "cevimeline hydrochloride", "labeler_name": "Lupin Pharmaceuticals,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"}