Bethanechol Chloride

Product NDC
53746-573
11-digit product format
537460573
Labeler code
53746
Product ID
53746-573_18da1d47-681c-49d7-a3ce-487dc57405f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA040855
Marketing category
ANDA
Marketing start
2022-04-15
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
2027-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040855-001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21
A040855-002BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21
A040855-003BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21
A040855-004BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-001BETHANECHOL CHLORIDE5MGTABLET / ORALAARS2007-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-002BETHANECHOL CHLORIDE10MGTABLET / ORALAARS2007-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-003BETHANECHOL CHLORIDE25MGTABLET / ORALAARS2007-11-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-004BETHANECHOL CHLORIDE50MGTABLET / ORALAARS2007-11-21d8e5a09893c0…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040855-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040855-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040855-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040855-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040855-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040855-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040855-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040855-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040855-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040855-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040855-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040855-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040855-004AA1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Bethanechol Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETHANECHOL CHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H4QBZ2LO84Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
857321Internal RxNorm lookup
857328Internal RxNorm lookup
857336Internal RxNorm lookup
857340Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16523451-cd3d-4c10-be06-d59a6f12ac68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92b44811-8b40-083f-6ae6-fb73b958b054Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-573-01Bethanechol Chloride100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-573-01EA - Each53746-573e2c901d6-26c5-4f6f-8c98-6084045cd68e12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-573BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]4Current NDC, Legacy NDC, 1 package rows20240118_16523451-cd3d-4c10-be06-d59a6f12ac68.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bethanechol ChlorideBETHANECHOL CHLORIDEAmneal Pharmaceuticals of New York LLC16523451-cd3d-4c10-be06-d59a6f12ac682026-01-29Adverse reactionsExact identifier
application applno (ANDA): 040855
application number: ANDA040855
ndc (product): 53746-573
Bethanechol ChlorideBETHANECHOL CHLORIDEAmerican Health Packagingda12a817-9f34-4f26-a7dc-e0e8f9be91c32024-12-02Adverse reactionsExact identifier
application applno (ANDA): 040855
application number: ANDA040855
Bethanechol ChlorideBETHANECHOL CHLORIDEAmneal Pharmaceuticals LLC45285692-de51-413e-8a51-7fb792eccc812024-10-23Adverse reactionsExact identifier
application applno (ANDA): 040855
application number: ANDA040855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857328bethanechol chloride 25 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857336bethanechol chloride 5 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857340bethanechol chloride 50 MG Oral TabletPSN16523451-cd3d-4c10-be06-d59a6f12ac685
857321bethanechol chloride 10 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857328bethanechol chloride 25 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857336bethanechol chloride 5 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857340bethanechol chloride 50 MG Oral TabletSCD16523451-cd3d-4c10-be06-d59a6f12ac685
857321bethanechol chloride 10 MG Oral TabletPSNda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857328bethanechol chloride 25 MG Oral TabletPSNda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857321bethanechol chloride 10 MG Oral TabletSCDda12a817-9f34-4f26-a7dc-e0e8f9be91c32
857328bethanechol chloride 25 MG Oral TabletSCDda12a817-9f34-4f26-a7dc-e0e8f9be91c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-573-0153746057301100 TABLET in 1 BOTTLE (53746-573-01) 100 tablet2022-04-150000-00-00NoNoCurrent