Home NDC 60687-689 Bethanechol Chloride
Product NDC 60687-689
11-digit product format 606870689
Labeler code 60687
Product ID 60687-689_284e319a-5266-f783-e063-6394a90a7a51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler American Health Packaging
Application ANDA040855
Marketing category ANDA
Marketing start 2022-08-17
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-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 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857321 Internal RxNorm lookup 857328 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 60687-689-01 Bethanechol Chloride 100 in 1 CARTON TABLET 100 2 60687-689-11 Bethanechol Chloride 1 in 1 BLISTER PACK TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-689 BETHANECHOL CHLORIDE TABLET [AMERICAN HEALTH PACKAGING] 2 Current NDC, Legacy NDC, 2 package rows 20241204_da12a817-9f34-4f26-a7dc-e0e8f9be91c3.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 60687-689-01 60687068901 100 BLISTER PACK in 1 CARTON (60687-689-01) / 1 TABLET in 1 BLISTER PACK (60687-689-11) 100 blister pack 2022-08-17 0000-00-00 No No Current 60687-689-11 60687068911 1 in 1 BLISTER PACK Historical