cevimeline hydrochloride

Product NDC: 0054-0893
11-digit product format: 000540893
Labeler code: 0054
Product ID: 0054-0893_dbda2680-d8e3-4df1-b9a2-f39cabe354f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cevimeline hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA091591
Marketing category: ANDA
Marketing start: 2026-10-05
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 44.

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
A091591-001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB		2013-07-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091591-001	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.

Product history page 1 of 2 · 44 observed 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
2026-10-15 13:18:30	2026-09	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091591-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2013-07-08	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091591-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091591-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091591-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091591-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091591-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091591-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091591-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091591-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091591-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091591-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091591-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091591-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091591-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091591-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091591-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091591-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091591-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091591-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091591-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091591-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091591-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091591-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091591-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091591-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091591-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091591-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091591-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091591-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091591-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091591-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091591-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091591-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091591-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091591-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091591-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091591-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091591-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091591-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091591-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091591-001	AB	1	`3a93d1ddd44b…`

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

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	fe30c870-a060-4a5b-ae61-6a9933854419	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091591 application number: ANDA091591
Cevimeline Hydrochloride	CEVIMELINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1167360c-7e0f-4619-9d1a-ad4ee56cab71	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091591 application number: ANDA091591

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
0054-0893-25	00054089325	100 CAPSULE in 1 BOTTLE (0054-0893-25)	100 capsule	2026-10-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cevimeline Hydrochloride Capsules	Hikma Pharmaceuticals USA Inc. \| Hikma Pharmaceuticals LLC	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	2