Home NDC 64980-160 BETHANECHOL CHLORIDE
Product NDC 64980-160
11-digit product format 649800160
Labeler code 64980
Product ID 64980-160_0f85faea-c7b6-4ea2-a5b4-08fb5daa4fd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BETHANECHOL CHLORIDE
Dosage form TABLET
Route ORAL
Labeler Rising Pharmaceuticals Inc.
Application ANDA091256
Marketing category ANDA
Marketing start 2010-08-24
Marketing end 0000-00-00
Substance BETHANECHOL CHLORIDE
Active strength 5 mg/1
Pharmacologic classes Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64980-160-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64980-160-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64980-160-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64980-160-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64980-160-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64980-160-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64980-160-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64980-160-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64980-160-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64980-160-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64980-160-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64980-160-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64980-160-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 64980-160-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 64980-160-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 64980-160-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 64980-160-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 64980-160-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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# 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 [RISING PHARMACEUTICALS INC.] 3 BETHANECHOL ACTIVE MOIETY 004F72P8F4 BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETHANECHOL CHLORIDE TABLET [RISING PHARMACEUTICALS INC.] 3 BETHANECHOL CHLORIDE ACTIVE INGREDIENT H4QBZ2LO84 BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 BETHANECHOL ACTIVE MOIETY 004F72P8F4 BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETHANECHOL CHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
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.