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 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 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.
Product history page 1 of 2 · 43 observed 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 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091591-001 CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB 2013-07-08 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 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
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 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