Home NDC 23155-934 Bethanechol Chloride
Product NDC 23155-934
11-digit product format 231550934
Labeler code 23155
Product ID 23155-934_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 5 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091256-001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2010-05-04 A091256-002 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2010-05-04 A091256-003 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2010-05-04 A091256-004 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2010-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2010-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2010-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2010-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2010-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2010-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2010-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2010-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2010-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2010-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2010-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2010-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2010-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2010-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2010-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2010-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2010-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 d8e5a09893c0…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Bethanechol Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETHANECHOL CHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H4QBZ2LO84 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857321 Internal RxNorm lookup 857328 Internal RxNorm lookup 857336 Internal RxNorm lookup 857340 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 23155-934-01 Bethanechol Chloride 100 in 1 BOTTLE TABLET 100 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 23155-934-01 23155093401 100 TABLET in 1 BOTTLE (23155-934-01) 100 tablet 2025-06-30 No No Current