Home NDC 0832-0511 Bethanechol Chloride
Product NDC 0832-0511
11-digit product format 008320511
Labeler code 0832
Product ID 0832-0511_4e037f1e-225e-4270-8967-088c8af3a1a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA040634
Marketing category ANDA
Marketing start 2010-01-24
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040634-001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040634-001 AA
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 2 · 43 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 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040634-001 BETHANECHOL CHLORIDE 10MG TABLET / ORAL AA 2005-06-01 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Bethanechol Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETHANECHOL CHLORIDE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-0511-00 Bethanechol Chloride 100 in 1 BOTTLE TABLET 100 13 0832-0511-01 Bethanechol Chloride 100 in 1 CARTON TABLET 100 13 0832-0511-10 Bethanechol Chloride 1000 in 1 BOTTLE TABLET 1000 13 0832-0511-25 Bethanechol Chloride 250 in 1 BOTTLE TABLET 250 13 0832-0511-89 Bethanechol Chloride 1 in 1 BLISTER PACK TABLET 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bethanechol Chloride ACTIVE INGREDIENT H4QBZ2LO84 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 Bethanechol ACTIVE MOIETY 004F72P8F4 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-0511 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 5 package rows 20240301_80393410-dd51-4cac-b27c-50ece00cca37.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0832-0511-00 00832051100 100 TABLET in 1 BOTTLE (0832-0511-00) 100 tablet 2010-01-24 0000-00-00 No No Current 0832-0511-01 00832051101 100 BLISTER PACK in 1 CARTON (0832-0511-01) / 1 TABLET in 1 BLISTER PACK (0832-0511-89) 100 blister pack 2010-01-24 0000-00-00 No No Current 0832-0511-10 00832051110 1000 TABLET in 1 BOTTLE (0832-0511-10) 1000 tablet 2010-01-24 0000-00-00 No No Current 0832-0511-25 00832051125 250 TABLET in 1 BOTTLE (0832-0511-25) 250 tablet 2010-01-24 0000-00-00 No No Current 0832-0511-89 00832051189 1 in 1 BLISTER PACK Historical