Cevimeline Hydrochloride

Product NDC: 59651-422
11-digit product format: 596510422
Labeler code: 59651
Product ID: 59651-422_d08d8aa5-76a4-417a-a308-7d195865522f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cevimeline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA215056
Marketing category: ANDA
Marketing start: 2023-04-18
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

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
unfinished product	product	59651-422		UNFINISHED	Active or certified unfinished drug listing		2026-09-14
unfinished package	package	59651-422	59651-422-15	UNFINISHED	Active or certified unfinished drug listing		2026-09-14

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	59651-422-15	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	59651-422-15	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	59651-422-15	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	59651-422-15	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	59651-422-15	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	59651-422-15	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	59651-422-15	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	59651-422-15	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	59651-422-15	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	59651-422-15	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	59651-422-15	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	59651-422-15	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	59651-422-15	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	59651-422-15	`50b4072663b7…`	`eae3003ed65e…`

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
A215056-001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB		2023-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A215056-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215056-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215056-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215056-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215056-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215056-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215056-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215056-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215056-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215056-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215056-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215056-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215056-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215056-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215056-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215056-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215056-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215056-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215056-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215056-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215056-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215056-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215056-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215056-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215056-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215056-001	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d08d8aa5-76a4-417a-a308-7d195865522f	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-422-01	Cevimeline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		1
59651-422-05	Cevimeline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-422-01	EA - Each	59651-422	69aee4e3-3e76-46de-a861-ab67f9570041	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-422	CEVIMELINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]	1	Current NDC, 2 package rows	20230425_d08d8aa5-76a4-417a-a308-7d195865522f.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	71ada1b0-3344-4202-9277-57f1a37402c1	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215056 application number: ANDA215056
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Aurobindo Pharma Limited	d08d8aa5-76a4-417a-a308-7d195865522f	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215056 application number: ANDA215056 ndc (product): 59651-422

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	71ada1b0-3344-4202-9277-57f1a37402c1	100
309140	cevimeline hydrochloride 30 MG Oral Capsule	SCD	71ada1b0-3344-4202-9277-57f1a37402c1	100
309140	cevimeline HCl 30 MG Oral Capsule	PSN	d08d8aa5-76a4-417a-a308-7d195865522f	1
309140	cevimeline hydrochloride 30 MG Oral Capsule	SCD	d08d8aa5-76a4-417a-a308-7d195865522f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59651-422-01	59651042201	100 CAPSULE in 1 BOTTLE (59651-422-01)	100 capsule	2023-04-18	No	No	Current
59651-422-05	59651042205	500 CAPSULE in 1 BOTTLE (59651-422-05)	500 capsule	2023-04-18	No	No	Current
59651-422-15	59651042215	1500 CAPSULE in 1 BAG (59651-422-15)	1500 capsule	18-APR-23			Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cevimeline Hydrochloride Capsules Rx only	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	100
Cevimeline Hydrochloride Capsules Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2023-04-19	Human Prescription Drug Label	1