Cevimeline

Product NDC: 63304-479
11-digit product format: 633040479
Labeler code: 63304
Product ID: 63304-479_558c3230-3788-4ef0-a5b5-3c06870317a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cevimeline
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA020989
Marketing category: NDA
Marketing start: 2016-03-10
Marketing end: 2027-04-30
Substance: CEVIMELINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag: No
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

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
773a19e8-4c3e-4414-99a6-aea98c9790ee	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
63304-479-01	Cevimeline	100 in 1 BOTTLE	CAPSULE	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-479-01	EA - Each	63304-479	404d1bfc-b705-4181-b6ac-37cf5c5c57f4	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEVIMELINE HYDROCHLORIDE	ACTIVE INGREDIENT	P81Q6V85NP	CEVIMELINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	1
CEVIMELINE	ACTIVE MOIETY	K9V0CDQ56E	CEVIMELINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	CEVIMELINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CEVIMELINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEVIMELINE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-479	CEVIMELINE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20220721_773a19e8-4c3e-4414-99a6-aea98c9790ee.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 ndc (product): 63304-479

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P81Q6V85NP	CEVIMELINE HYDROCHLORIDE	153504-70-2	CEVIMELINE HYDROCHLORIDE
K9V0CDQ56E	CEVIMELINE	107233-08-9	Cevimeline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309140	cevimeline HCl 30 MG Oral Capsule	PSN	773a19e8-4c3e-4414-99a6-aea98c9790ee	10
309140	cevimeline hydrochloride 30 MG Oral Capsule	SCD	773a19e8-4c3e-4414-99a6-aea98c9790ee	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-479-01	63304047901	100 CAPSULE in 1 BOTTLE (63304-479-01)	100 capsule	2016-03-10	2027-04-30	No	No	Current