Home NDC 0713-0937 cevimeline hydrochloride
Product NDC 0713-0937
11-digit product format 007130937
Labeler code 0713
Product ID 0713-0937_f183f958-57f5-ea10-e053-2995a90a5ead
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cevimeline hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Cosette Pharmaceuticals, Inc.
Application NDA020989
Marketing category NDA
Marketing start 2023-01-03
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 N020989-002 EVOXAC CEVIMELINE HYDROCHLORIDE 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020989-002 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 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020989-002 EVOXAC 30MG CAPSULE / ORAL AB RLD, RS 2000-01-11 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 0713-0937-01 cevimeline hydrochloride 100 in 1 BOTTLE, PLASTIC CAPSULE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0937 CEVIMELINE HYDROCHLORIDE CAPSULE [COSETTE PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20230106_efc2bb24-4dda-4781-bef5-fcd9abf082dd.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 · 4 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 0713-0937-01 00713093701 100 CAPSULE in 1 BOTTLE, PLASTIC (0713-0937-01) 100 capsule 2023-01-03 0000-00-00 No No Current