Application 040855

Type: ANDA
Sponsor: AMNEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	TABLET;ORAL	5MG	No	Yes
002	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	TABLET;ORAL	10MG	No	Yes
003	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	TABLET;ORAL	25MG	No	Yes
004	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040855-001	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21
A040855-002	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21
A040855-003	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21
A040855-004	BETHANECHOL CHLORIDE	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A040855-001	AA
A040855-002	AA
A040855-003	AA
A040855-004	AA

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 5 · 168 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
2026-08-18 06:07:40	2026-07	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-001	BETHANECHOL CHLORIDE	5MG	TABLET / ORAL	AA	RS	2007-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-002	BETHANECHOL CHLORIDE	10MG	TABLET / ORAL	AA	RS	2007-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-003	BETHANECHOL CHLORIDE	25MG	TABLET / ORAL	AA	RS	2007-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-004	BETHANECHOL CHLORIDE	50MG	TABLET / ORAL	AA	RS	2007-11-21	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040855-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-003	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040855-004	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040855-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-003	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040855-004	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-003	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040855-004	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040855-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-003	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040855-004	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-003	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040855-004	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-003	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040855-004	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-003	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040855-004	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-003	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040855-004	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-003	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040855-004	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-003	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040855-004	AA	1	`d8e5a09893c0…`

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
Bethanechol Chloride	BETHANECHOL CHLORIDE	Amneal Pharmaceuticals of New York LLC	16523451-cd3d-4c10-be06-d59a6f12ac68	2026-01-29	Adverse reactions	Exact identifier application applno (ANDA): 040855 application number: ANDA040855 ndc (product): 53746-572 ndc (product): 53746-574 ndc (product): 53746-573 ndc (product): 53746-571
Bethanechol Chloride	BETHANECHOL CHLORIDE	American Health Packaging	da12a817-9f34-4f26-a7dc-e0e8f9be91c3	2024-12-02	Adverse reactions	Exact identifier application applno (ANDA): 040855 application number: ANDA040855 ndc (product): 60687-689 ndc (product): 60687-700
Bethanechol Chloride	BETHANECHOL CHLORIDE	Amneal Pharmaceuticals LLC	45285692-de51-413e-8a51-7fb792eccc81	2024-10-23	Adverse reactions	Exact identifier application applno (ANDA): 040855 application number: ANDA040855 ndc (product): 65162-573 ndc (product): 65162-572 ndc (product): 65162-574 ndc (product): 65162-571

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7912	Bethanechol Chloride	Bethanechol Chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6178	Bethanechol Chloride	Bethanechol Chloride	Major Pharmaceuticals	ANDA	Current
0904-6178	Bethanechol Chloride	Bethanechol Chloride	Major Pharmaceuticals	ANDA	Current
0904-6178	Bethanechol Chloride	Bethanechol Chloride	Major Pharmaceuticals	ANDA	Current
50268-113	Bethanechol Chloride	Bethanechol Chloride	AvPAK	ANDA	Current
50268-114	Bethanechol Chloride	Bethanechol Chloride	AvPAK	ANDA	Current
53746-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
53746-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals of New York LLC	ANDA	Current
55700-382	Bethanechol Chloride	Bethanechol Chloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-689	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
60687-700	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
65162-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-571	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-572	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-573	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
65162-574	Bethanechol Chloride	Bethanechol Chloride	Amneal Pharmaceuticals LLC	ANDA	Current
68084-365	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-365	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-365	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-365	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-365	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-704	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-704	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-704	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-704	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
68084-704	Bethanechol Chloride	Bethanechol Chloride	American Health Packaging	ANDA	Current
71335-0846	Bethanechol Chloride	Bethanechol Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0846	Bethanechol Chloride	Bethanechol Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0846	Bethanechol Chloride	Bethanechol Chloride	Bryant Ranch Prepack	ANDA	Current