Home NDC 0527-1340 Bethanechol Chloride
Product NDC 0527-1340
11-digit product format 005271340
Labeler code 0527
Product ID 0527-1340_747a1dfb-7e27-4592-8816-b2d91caa9012
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA040677
Marketing category ANDA
Marketing start 2008-03-27
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 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1340-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1340-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1340-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1340-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1340-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1340-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1340-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1340-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1340-01 0efc9e666f02…f202fb6c5f17…
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 A040677-001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 A040677-002 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 A040677-003 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 A040677-004 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27
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 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040677-001 BETHANECHOL CHLORIDE 50MG TABLET / ORAL 2008-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040677-002 BETHANECHOL CHLORIDE 5MG TABLET / ORAL 2008-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040677-003 BETHANECHOL CHLORIDE 10MG TABLET / ORAL 2008-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040677-004 BETHANECHOL CHLORIDE 25MG TABLET / ORAL 2008-03-27 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BETHANECHOL CHLORIDE ACTIVE INGREDIENT H4QBZ2LO84 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 BETHANECHOL ACTIVE MOIETY 004F72P8F4 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 SODIUM STARCH GLYCOLATE TYPE B POTATO INACTIVE INGREDIENT 27NA468985 BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-1340-01 00527134001 100 TABLET in 1 BOTTLE (0527-1340-01) 100 tablet 2008-03-27 0000-00-00 No No Current