Home NDC 33342-216 Cevimeline Hydrochloride
Product NDC 33342-216
11-digit product format 333420216
Labeler code 33342
Product ID 33342-216_67215459-3dd7-4538-9938-7d7315607fb6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cevimeline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA206808
Marketing category ANDA
Marketing start 2024-10-20
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 A206808-001 CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206808-001 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 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206808-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2024-09-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 33342-216-11 Cevimeline Hydrochloride 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-216 CEVIMELINE HYDROCHLORIDE CAPSULE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20241129_990887c1-11ce-4a73-83b4-0ffc5a900c85.zip
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 · 1 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 33342-216-11 33342021611 100 CAPSULE in 1 BOTTLE (33342-216-11) 100 capsule 2024-10-20 No No Current