Home NDC 72578-208 Cevimeline Hydrochloride
Product NDC 72578-208
11-digit product format 725780208
Labeler code 72578
Product ID 72578-208_4518aba1-9402-4137-a7f0-6b24ec60efda
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cevimeline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Viona Pharmaceuticals Inc
Application ANDA220267
Marketing category ANDA
Marketing start 2026-04-15
Substance CEVIMELINE HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220267-001 CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2026-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220267-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A220267-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2026-03-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220267-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2026-03-11 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220267-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2026-03-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220267-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220267-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220267-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cevimeline Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEVIMELINE HYDROCHLORIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P81Q6V85NP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309140 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72578-208-01 Cevimeline Hydrochloride 100 in 1 BOTTLE CAPSULE 100 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72578-208-01 72578020801 100 CAPSULE in 1 BOTTLE (72578-208-01) 100 capsule 2026-04-15 No No Current