Bethanechol Chloride

Product NDC
23155-935
11-digit product format
231550935
Labeler code
23155
Product ID
23155-935_ffe9461d-3417-4da1-af45-185d7b3bd2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
Application
ANDA091256
Marketing category
ANDA
Marketing start
2025-06-30
Substance
BETHANECHOL CHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A091256-001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE5MGTABLET / ORALAA2010-05-04
A091256-002BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE10MGTABLET / ORALAA2010-05-04
A091256-003BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE25MGTABLET / ORALAA2010-05-04
A091256-004BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE50MGTABLET / ORALAA2010-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091256-001AA
A091256-002AA
A091256-003AA
A091256-004AA

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 06:07:402026-07A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORALAA2010-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORALAA2010-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORALAA2010-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORALAA2010-05-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORALAA2010-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORALAA2010-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORALAA2010-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORALAA2010-05-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORALAA2010-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORALAA2010-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORALAA2010-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORALAA2010-05-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORALAA2010-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORALAA2010-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORALAA2010-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORALAA2010-05-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091256-001BETHANECHOL CHLORIDE5MGTABLET / ORAL2010-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091256-002BETHANECHOL CHLORIDE10MGTABLET / ORAL2010-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091256-003BETHANECHOL CHLORIDE25MGTABLET / ORAL2010-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091256-004BETHANECHOL CHLORIDE50MGTABLET / ORAL2010-05-04d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091256-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A091256-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091256-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091256-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091256-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091256-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091256-004AA16a471c1ec25d…
2019-12-13 00:20 UTC2019-12A091256-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091256-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091256-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091256-004AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A091256-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A091256-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A091256-003AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A091256-004AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A091256-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091256-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091256-003AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091256-004AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091256-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091256-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091256-003AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091256-004AA1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091256-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091256-002AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091256-003AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091256-004AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Bethanechol Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETHANECHOL CHLORIDE10 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
11ba3d38-a61b-4b03-ba03-4ccf2e450d1fAvailable 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
23155-935-01Bethanechol Chloride100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-935-01EA - Each23155-935a4fb1478-0f24-4aec-8245-0d3177a311f312025-07-08

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bethanechol ChlorideBETHANECHOL CHLORIDEHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2025-10-27Adverse reactionsExact identifier
application applno (ANDA): 091256
application number: ANDA091256
ndc (product): 23155-935

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857321bethanechol chloride 10 MG Oral TabletPSN11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857328bethanechol chloride 25 MG Oral TabletPSN11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857336bethanechol chloride 5 MG Oral TabletPSN11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857340bethanechol chloride 50 MG Oral TabletPSN11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857321bethanechol chloride 10 MG Oral TabletSCD11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857328bethanechol chloride 25 MG Oral TabletSCD11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857336bethanechol chloride 5 MG Oral TabletSCD11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2
857340bethanechol chloride 50 MG Oral TabletSCD11ba3d38-a61b-4b03-ba03-4ccf2e450d1f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-935-0123155093501100 TABLET in 1 BOTTLE (23155-935-01) 100 tablet2025-06-30NoNoCurrent