Evoxac

Product NDC: 63395-201
11-digit product format: 633950201
Labeler code: 63395
Product ID: 63395-201_24b744ff-3334-424d-9500-76dbfca5979a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cevimeline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Daiichi Sankyo, Inc.
Application: NDA020989
Marketing category: NDA
Marketing start: 2000-01-12
Marketing end: 2025-08-31
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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63395-201		D	Discontinued by firm		2026-10-02
excluded package	package	63395-201	63395-201-13	D	Discontinued by firm		2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	63395-201		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63395-201	63395-201-13	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020989-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020989-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020989-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020989-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020989-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020989-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020989-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020989-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020989-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020989-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020989-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020989-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020989-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020989-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020989-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020989-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020989-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020989-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020989-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020989-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020989-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020989-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020989-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020989-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020989-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020989-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020989-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020989-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020989-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020989-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020989-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020989-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020989-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020989-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020989-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020989-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020989-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020989-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020989-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020989-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ee6cfc6-9666-4038-bf74-eee52d7e4a72	Product name	4	20250331

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63395-201-13	2020-08-21	C162847	48780-1	ab0e2407-2eee-f274-e053-dbdaa90a6471	EVOXAC ® Capsules (cevimeline hydrochloride)
63395-201-13	2020-07-22	C162847	48780-1	ab0e2407-2eee-f274-e053-dbdaa90a6471	EVOXAC ® Capsules (cevimeline hydrochloride)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63395-201-13	EA - Each	63395-201	9fb1f160-a03b-4679-a812-d432f63322af	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEVIMELINE HYDROCHLORIDE	ACTIVE INGREDIENT	P81Q6V85NP	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO PHARMA DEVELOPMENT]	3
CEVIMELINE	ACTIVE MOIETY	K9V0CDQ56E	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO PHARMA DEVELOPMENT]	3
CEVIMELINE HYDROCHLORIDE	ACTIVE INGREDIENT	P81Q6V85NP	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
CEVIMELINE	ACTIVE MOIETY	K9V0CDQ56E	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63395-201	EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO, INC.]	14	Legacy NDC	20220608_0679dd4c-fece-4c6d-b273-2c62237e8973.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	7fa69ad5-7fa7-4078-9328-aacbb0d145a4	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020989 application number: NDA020989
cevimeline hydrochloride	CEVIMELINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	efc2bb24-4dda-4781-bef5-fcd9abf082dd	2023-01-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020989 application number: NDA020989
Evoxac	CEVIMELINE HYDROCHLORIDE	Cosette Pharmaceuticals, Inc.	dac32a9b-05b8-42c2-9a29-d885a9279456	2022-09-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020989 application number: NDA020989
Cevimeline	CEVIMELINE	Sun Pharmaceutical Industries, Inc.	773a19e8-4c3e-4414-99a6-aea98c9790ee	2022-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020989 application number: NDA020989

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P81Q6V85NP	CEVIMELINE HYDROCHLORIDE	153504-70-2	CEVIMELINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309140	cevimeline HCl 30 MG Oral Capsule	PSN	bf6bebde-81ef-4a49-bd8b-2b7444f7adbf	1
261361	Evoxac 30 MG Oral Capsule	PSN	bf6bebde-81ef-4a49-bd8b-2b7444f7adbf	1
261361	cevimeline hydrochloride 30 MG Oral Capsule [Evoxac]	SBD	bf6bebde-81ef-4a49-bd8b-2b7444f7adbf	1
309140	cevimeline hydrochloride 30 MG Oral Capsule	SCD	bf6bebde-81ef-4a49-bd8b-2b7444f7adbf	1
261361	Evoxac 30 MG Oral Capsule	SY	bf6bebde-81ef-4a49-bd8b-2b7444f7adbf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63395-201-13	63395020113	100 CAPSULE in 1 BOTTLE, PLASTIC (63395-201-13)	100 capsule	2000-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EVOXAC ® Capsules (cevimeline hydrochloride)	Daiichi Sankyo, Inc.	2022-06-03	HUMAN PRESCRIPTION DRUG LABEL	14
EVOXAC - STAT RX USA LLC	STAT RX USA LLC	2011-08-02	HUMAN PRESCRIPTION DRUG LABEL	1