cevimeline hydrochloride

Generic: cevimeline hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cevimeline hydrochloride 30 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-457
Product ID 72789-457_48d8a76e-8103-9485-e063-6294a90af9ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216682
Listing Expiration 2027-12-31
Marketing Start 2023-04-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72789457
Hyphenated Format 72789-457

Supplemental Identifiers

RxCUI
309140
UNII
P81Q6V85NP

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 ANDA216682 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01)
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)
source: ndc

Packages (2)

72789-457-01 100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01) 72789-457-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)

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": "48d8a76e-8103-9485-e063-6294a90af9ab", "openfda": {"unii": ["P81Q6V85NP"], "rxcui": ["309140"], "spl_set_id": ["2b429ea7-1c7c-47a4-803c-2546736f5c36"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01)", "package_ndc": "72789-457-01", "marketing_start_date": "20241230"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)", "package_ndc": "72789-457-30", "marketing_start_date": "20241230"}], "brand_name": "CEVIMELINE HYDROCHLORIDE", "product_id": "72789-457_48d8a76e-8103-9485-e063-6294a90af9ab", "dosage_form": "CAPSULE", "pharm_class": ["Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "72789-457", "generic_name": "CEVIMELINE HYDROCHLORIDE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEVIMELINE HYDROCHLORIDE", "active_ingredients": [{"name": "CEVIMELINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "ANDA216682", "marketing_category": "ANDA", "marketing_start_date": "20230406", "listing_expiration_date": "20271231"}