Home NDC 0054-0334 Cevimeline Hydrochloride
Product NDC 0054-0334
11-digit product format 000540334
Labeler code 0054
Product ID 0054-0334_3cca3720-dca8-40cf-8de7-8f3444125ece
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cevimeline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA091591
Marketing category ANDA
Marketing start 2013-07-08
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091591-001 CEVIMELINE HYDROCHLORIDE CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091591-001 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 2026-08-01 22:54:32 2026-06 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091591-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Cevimeline Hydrochloride
Listing expiration 2026-12-31 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 0054-0334-25 Cevimeline Hydrochloride 100 in 1 BOTTLE CAPSULE 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEVIMELINE HYDROCHLORIDE ACTIVE INGREDIENT P81Q6V85NP CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 CEVIMELINE ACTIVE MOIETY K9V0CDQ56E CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CEVIMELINE HYDROCHLORIDE CAPSULE [ROXANE LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0334 CEVIMELINE HYDROCHLORIDE CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 1 package rows 20240913_1167360c-7e0f-4619-9d1a-ad4ee56cab71.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0334-25 00054033425 100 CAPSULE in 1 BOTTLE (0054-0334-25) 100 capsule 2013-07-08 0000-00-00 No No Current