Home NDC 0832-0512 Bethanechol Chloride
Product NDC 0832-0512
11-digit product format 008320512
Labeler code 0832
Product ID 0832-0512_4617beb7-3829-8994-e063-6394a90a14b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bethanechol Chloride
Dosage form TABLET
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA040635
Marketing category ANDA
Marketing start 2010-01-24
Substance BETHANECHOL CHLORIDE
Active strength 25 mg/1
Pharmacologic classes Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A040635-001 BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE 25MG 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 A040635-001 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 · 42 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 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040635-001 BETHANECHOL CHLORIDE 25MG TABLET / ORAL AA 2005-06-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Bethanechol Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETHANECHOL CHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination H4QBZ2LO84 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857321 Internal RxNorm lookup 857328 Internal RxNorm lookup 857336 Internal RxNorm lookup 857340 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0832-0512-00 Bethanechol Chloride 100 in 1 BOTTLE TABLET 100 13 0832-0512-01 Bethanechol Chloride 100 in 1 CARTON TABLET 100 13 0832-0512-10 Bethanechol Chloride 1000 in 1 BOTTLE TABLET 1000 13 0832-0512-25 Bethanechol Chloride 250 in 1 BOTTLE TABLET 250 13 0832-0512-50 Bethanechol Chloride 500 in 1 BOTTLE TABLET 500 13 0832-0512-89 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 0832-0512 BETHANECHOL CHLORIDE TABLET [UPSHER-SMITH LABORATORIES, LLC] 11 Current NDC, Legacy NDC, 6 package rows 20240301_80393410-dd51-4cac-b27c-50ece00cca37.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.
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 0832-0512-00 00832051200 100 TABLET in 1 BOTTLE (0832-0512-00) 100 tablet 2010-01-24 0000-00-00 No No Current 0832-0512-01 00832051201 100 BLISTER PACK in 1 CARTON (0832-0512-01) / 1 TABLET in 1 BLISTER PACK (0832-0512-89) 100 blister pack 2010-01-24 0000-00-00 No No Current 0832-0512-10 00832051210 1000 TABLET in 1 BOTTLE (0832-0512-10) 1000 tablet 2010-01-24 0000-00-00 No No Current 0832-0512-25 00832051225 250 TABLET in 1 BOTTLE (0832-0512-25) 250 tablet 2010-01-24 0000-00-00 No No Current 0832-0512-50 00832051250 500 TABLET in 1 BOTTLE (0832-0512-50) 500 tablet 2010-01-24 0000-00-00 No No Current 0832-0512-89 00832051289 1 in 1 BLISTER PACK Historical