Bethanechol Chloride

Product NDC
63629-2022
11-digit product format
636292022
Labeler code
63629
Product ID
63629-2022_19d09d25-5f8d-4519-9ef6-94f83da41262
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bethanechol Chloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040728
Marketing category
ANDA
Marketing start
2020-02-15
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 productproduct63629-2022DDiscontinued by firm2026-08-17
excluded packagepackage63629-202263629-2022-1DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040728-001BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26
A040728-002BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26
A040728-003BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26
A040728-004BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A040728-001AA
A040728-002AA
A040728-003AA
A040728-004AA

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 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-001BETHANECHOL CHLORIDE50MGTABLET / ORALAA2007-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-002BETHANECHOL CHLORIDE5MGTABLET / ORALAA2007-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-003BETHANECHOL CHLORIDE10MGTABLET / ORALAA2007-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-004BETHANECHOL CHLORIDE25MGTABLET / ORALAA2007-10-26d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040728-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-003AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040728-004AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040728-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-003AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040728-004AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-003AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040728-004AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040728-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-003AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040728-004AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-002AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-003AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040728-004AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-003AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040728-004AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-003AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040728-004AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-003AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040728-004AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-003AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040728-004AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-003AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040728-004AA1d8e5a09893c0…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2022-1EA - Each63629-20220f83817b-6d7d-44f9-8722-8ebccb1f14e812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2022BETHANECHOL CHLORIDE TABLET [BRYANT RANCH PREPACK]102Legacy NDC20230225_f3b225dc-1951-42b1-bb8e-5db48c31ec89.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bethanechol ChlorideBETHANECHOL CHLORIDEChartwell RX, LLC89267333-ba8b-455b-a8dc-515a888463c22024-01-22Adverse reactionsExact identifier
application applno (ANDA): 040728
application number: ANDA040728

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2022-163629202201100 TABLET in 1 BOTTLE (63629-2022-1) 100 tablet2021-01-180000-00-00NoNoCurrent