Home NDC 65162-571 Bethanechol Chloride
Product NDC 65162-571
11-digit product format 651620571
Labeler code 65162
Product ID 65162-571_20630162-d16b-4671-a94a-618acea32787
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA040855
Marketing category ANDA
Marketing start 2007-11-21
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 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.
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.
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 65162-571-10 Bethanechol Chloride 100 in 1 BOTTLE TABLET 100 15 65162-571-11 Bethanechol Chloride 1000 in 1 BOTTLE TABLET 1000 15 65162-571-50 Bethanechol Chloride 500 in 1 BOTTLE TABLET 500 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETHANECHOL CHLORIDE ACTIVE INGREDIENT H4QBZ2LO84 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 BETHANECHOL ACTIVE MOIETY 004F72P8F4 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-571 BETHANECHOL CHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC] 15 Current NDC, Legacy NDC, 3 package rows 20241025_45285692-de51-413e-8a51-7fb792eccc81.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-571-10 65162057110 100 TABLET in 1 BOTTLE (65162-571-10) 100 tablet 2007-11-21 0000-00-00 No No Current 65162-571-11 65162057111 1000 TABLET in 1 BOTTLE (65162-571-11) 1000 tablet 2007-11-21 0000-00-00 No No Current 65162-571-50 65162057150 500 TABLET in 1 BOTTLE (65162-571-50) 500 tablet 2007-11-21 0000-00-00 No No Current