Bethanechol Chloride

Product NDC: 68084-704
Requested package NDC: 68084-704-01
11-digit product format: 680840704
Labeler code: 68084
Product ID: 68084-704_f0389bf7-bb25-095b-e053-2995a90a01e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bethanechol Chloride
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA040855
Marketing category: ANDA
Marketing start: 2015-02-05
Marketing end: 2023-12-31
Substance: BETHANECHOL CHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68084-704	68084-704-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-704-01	EA - Each	68084-704	2aa05759-585e-4fb2-a2d8-28a1ac79a287	1	2015-03-03
68084-704-11	EA - Each	68084-704	ccebbf64-282f-4b5d-aae7-d9f528756c4b	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETHANECHOL CHLORIDE	ACTIVE INGREDIENT	H4QBZ2LO84	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
BETHANECHOL	ACTIVE MOIETY	004F72P8F4	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING]	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 · 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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
H4QBZ2LO84	BETHANECHOL CHLORIDE	590-63-6	BETHANECHOL CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-704-01	68084070401	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-704-01) > 1 TABLET in 1 BLISTER PACK (68084-704-11)	100 blister pack	2015-02-05	2023-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bethanechol Chloride Tablets, USP 8236501/0519F Rx Only	American Health Packaging	2022-12-19	HUMAN PRESCRIPTION DRUG LABEL	8