cevimeline hydrochloride

Product NDC: 71335-3168
Requested package NDC: 71335-3168-2
11-digit product format: 713353168
Labeler code: 71335
Product ID: 71335-3168_0e5763b8-0263-43fa-beaa-7828aa1d5be4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cevimeline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
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: 2027-12-31
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.

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.

Additional Listing Data#

Finished product: Yes
Brand name base: cevimeline hydrochloride
Listing expiration: 2027-12-31

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
7fa69ad5-7fa7-4078-9328-aacbb0d145a4	Available on FDA.report

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 ndc (package): 71335-3168-2 ndc (product): 71335-3168 ndc11 (package): 71335316802
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-3168-2	71335316802	60 CAPSULE in 1 BOTTLE (71335-3168-2)	60 capsule	2026-08-04	No	No	Current