CEVIMELINE HYDROCHLORIDE

Product NDC: 72789-457
11-digit product format: 727890457
Labeler code: 72789
Product ID: 72789-457_5a0a54c1-aaa6-43d7-e063-6394a90a0057
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CEVIMELINE HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA216682
Marketing category: ANDA
Marketing start: 2023-04-06
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
A216682-001	CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB		2023-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216682-001	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	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216682-001	CEVIMELINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AB	2023-04-06	`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	A216682-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216682-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216682-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216682-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216682-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216682-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216682-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216682-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216682-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216682-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216682-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216682-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216682-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216682-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216682-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216682-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216682-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216682-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216682-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216682-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216682-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216682-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216682-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216682-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216682-001	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: 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
2b429ea7-1c7c-47a4-803c-2546736f5c36	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
72789-457-01	CEVIMELINE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		4
72789-457-30	CEVIMELINE HYDROCHLORIDE	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-457-01	EA - Each	72789-457	e74f0641-4b8c-4574-b719-f4070ebf98a2	1	2025-02-10
72789-457-30	EA - Each	72789-457	5df0187c-8070-4ae4-853f-354497d4d23e	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-457	CEVIMELINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20250101_2b429ea7-1c7c-47a4-803c-2546736f5c36.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	2b429ea7-1c7c-47a4-803c-2546736f5c36	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216682 application number: ANDA216682 ndc (product): 72789-457
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	Bryant Ranch Prepack	75ae16d6-8822-4581-b747-ae894a45cdea	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216682 application number: ANDA216682
CEVIMELINE HYDROCHLORIDE	CEVIMELINE HYDROCHLORIDE	Advagen Pharma Ltd	61dd5ee1-cf89-43ea-ada4-4e4a4d9d133b	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216682 application number: ANDA216682

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	2b429ea7-1c7c-47a4-803c-2546736f5c36	4
309140	cevimeline hydrochloride 30 MG Oral Capsule	SCD	2b429ea7-1c7c-47a4-803c-2546736f5c36	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-457-01	72789045701	100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01)	100 capsule	2024-12-30	No	No	Current
72789-457-30	72789045730	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30)	30 capsule	2024-12-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cevimeline hydrochloride Capsules 30mg	PD-Rx Pharmaceuticals, Inc.	2026-08-27	HUMAN PRESCRIPTION DRUG LABEL	5