Home NDC 51293-646-01 Bethanechol Chloride
Product NDC 51293-646
Requested package NDC 51293-646-01
11-digit product format 512930646
Labeler code 51293
Product ID 51293-646_a09fcea1-a58d-4333-a3cb-56766a74cac2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler ECI Pharmaceuticals LLC
Application ANDA040728
Marketing category ANDA
Marketing start 2020-02-15
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 160 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 2026-09-14 22:38:34 2026-08 A040728-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL AA 2007-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040728-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL AA 2007-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040728-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2007-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040728-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2007-10-26 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51293-646 BETHANECHOL CHLORIDE TABLET [ECI PHARMACEUTICALS LLC ] 1 Legacy NDC 20200302_1cf5ba26-17a3-4adc-8990-4853a4177c1e.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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51293-646-01 51293064601 100 TABLET in 1 BOTTLE (51293-646-01) 100 tablet 2020-02-15 0000-00-00 No No Current