Home Applications 091256 Application 091256
Type ANDA
Sponsor HERITAGE PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 5MG No No 002 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 10MG No No 003 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 25MG No No 004 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE TABLET;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 164 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 2026-02-19 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…2024-10-29 15:01 UTC 2024-10 A091256-001 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2010-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091256-002 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2010-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091256-003 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2010-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091256-004 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2010-05-04 d06236e962d9…
Observed Orange Book normalized TE history# 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 23155-676 bethanechol chloride bethanechol chloride Heritage Pharmaceuticals Inc. ANDA Current 23155-677 bethanechol chloride bethanechol chloride Heritage Pharmaceuticals Inc. ANDA Current 23155-678 bethanechol chloride bethanechol chloride Heritage Pharmaceuticals Inc. ANDA Current 23155-679 bethanechol chloride bethanechol chloride Heritage Pharmaceuticals Inc. ANDA Current 60429-340 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Golden State Medical Supply, Inc. ANDA Current 60429-342 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Golden State Medical Supply, Inc. ANDA Current 60429-343 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Golden State Medical Supply, Inc. ANDA Current 64980-160 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Rising Pharmaceuticals Inc. ANDA Current 64980-161 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Rising Pharmaceuticals Inc. ANDA Current 64980-162 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Rising Pharmaceuticals Inc. ANDA Current 64980-163 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE Rising Pharmaceuticals Inc. ANDA Current