Home Applications 040728 Application 040728
Type ANDA
Sponsor ECI PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 50MG No No 002 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 5MG No No 003 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 10MG No No 004 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 25MG No No
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 A040728-001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 A040728-002 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 A040728-003 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 A040728-004 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26
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 4 · 156 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 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 51293-645 Bethanechol Chloride Bethanechol Chloride ECI Pharmaceuticals LLC ANDA Current 51293-646 Bethanechol Chloride Bethanechol Chloride ECI Pharmaceuticals LLC ANDA Current 51293-647 Bethanechol Chloride Bethanechol Chloride ECI Pharmaceuticals LLC ANDA Current 51293-648 Bethanechol Chloride Bethanechol Chloride ECI Pharmaceuticals LLC ANDA Current 63629-2022 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2022 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2023 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2023 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2024 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2024 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2025 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-2025 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current 63629-9293 Bethanechol Chloride Bethanechol Chloride Bryant Ranch Prepack ANDA Current