Bethanechol Chloride

Product NDC
0527-1332
11-digit product format
005271332
Labeler code
0527
Product ID
0527-1332_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
5 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0527-1332DDiscontinued by firm2026-10-20
excluded packagepackage0527-13320527-1332-01DDiscontinued by firm2026-10-20

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0527-1332-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0527-1332-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0527-1332-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0527-1332-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0527-1332-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0527-1332-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0527-1332-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0527-1332-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0527-1332-010efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040677-001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27
A040677-002BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27
A040677-003BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27
A040677-004BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27c2088c7a36db…
2026-10-15 13:18:302026-09A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27c2088c7a36db…
2026-09-14 22:38:342026-08A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040677-001BETHANECHOL CHLORIDE50MGTABLET / ORAL2008-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040677-002BETHANECHOL CHLORIDE5MGTABLET / ORAL2008-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040677-003BETHANECHOL CHLORIDE10MGTABLET / ORAL2008-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040677-004BETHANECHOL CHLORIDE25MGTABLET / ORAL2008-03-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A040677-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040677-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040677-003AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040677-004AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040677-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040677-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040677-003AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040677-004AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040677-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040677-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040677-003AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040677-004AA1ea99ee380514…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040677-001AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040677-002AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040677-003AA13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040677-004AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040677-001AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040677-002AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040677-003AA1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040677-004AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040677-001AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A040677-002AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A040677-003AA1e64feba35796…
2022-09-29 23:25 UTC2022-09A040677-004AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040677-001AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040677-002AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040677-003AA1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040677-004AA1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1332-012024-01-30C16284748780-11030e365-1758-111a-e063-dadaa90a10e2Bethanechol Chloride Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1332-01EA - Each0527-133242508487-292f-4979-b21b-838dbdb541c212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETHANECHOL CHLORIDEACTIVE INGREDIENTH4QBZ2LO84BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
BETHANECHOLACTIVE MOIETY004F72P8F4BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985BETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UBETHANECHOL CHLORIDE TABLET [LANNETT COMPANY, INC.]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1332-0100527133201100 TABLET in 1 BOTTLE (0527-1332-01) 100 tablet2008-03-270000-00-00NoNoCurrent