Pyridostigmine Bromide

Product NDC
58657-810
11-digit product format
586570810
Labeler code
58657
Product ID
58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOSTIGMINE BROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA211181
Marketing category
ANDA
Marketing start
2019-06-01
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
30 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage58657-81058657-810-10DDiscontinued by firm2026-08-11
excluded packagepackage58657-81058657-810-30DDiscontinued by firm2026-08-11

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0558657-810-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0558657-810-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2658657-810-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2658657-810-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3158657-810-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3158657-810-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2858657-810-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2858657-810-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2158657-810-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2158657-810-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1058657-810-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1058657-810-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3158657-810-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3158657-810-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2058657-810-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2058657-810-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1058657-810-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1058657-810-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0858657-810-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0858657-810-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0358657-810-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0358657-810-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0958657-810-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0958657-810-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211181-001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20
A211181-002PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A211181-001AB
A211181-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORALAB2019-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211181-001PYRIDOSTIGMINE BROMIDE60MGTABLET / ORALAB2018-07-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A211181-002PYRIDOSTIGMINE BROMIDE30MGTABLET / ORAL2019-05-14782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211181-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211181-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211181-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211181-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211181-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211181-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211181-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211181-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211181-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211181-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211181-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211181-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211181-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211181-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211181-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211181-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211181-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211181-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211181-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211181-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211181-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211181-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211181-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211181-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211181-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211181-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211181-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211181-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211181-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211181-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211181-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211181-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211181-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211181-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211181-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211181-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211181-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211181-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211181-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211181-001AB1b00525d2431f…

Additional Listing Data#

Finished product
Yes
Brand name base
Pyridostigmine Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KVI301NA53Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903841Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e756717f-941b-42f2-ba3b-03798c005ae7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-810-10Pyridostigmine Bromide10 in 1 BLISTER PACKTABLET109
58657-810-10Pyridostigmine Bromide21 in 1 CARTONTABLET219
58657-810-21Pyridostigmine Bromide21 in 1 BOTTLETABLET219
58657-810-30Pyridostigmine Bromide30 in 1 CARTONTABLET309
58657-810-30Pyridostigmine Bromide3 in 1 CARTONTABLET39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-810-10EA - Each58657-8103f729235-2f08-4596-b6d8-e620879905e412020-06-05
58657-810-21EA - Each58657-8103afd0c04-5d77-473e-93c9-8cfeb0d139bf12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-810PYRIDOSTIGMINE BROMIDE TABLET [METHOD PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 5 package rows20241126_e756717f-941b-42f2-ba3b-03798c005ae7.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEMethod Pharmaceuticals, LLC1aa7a886-c726-cc91-e063-6294a90a1af12026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211181
application number: ANDA211181
Pyridostigmine BromidePYRIDOSTIGMINE BROMIDEMethod Pharmaceuticals, LLCe756717f-941b-42f2-ba3b-03798c005ae72025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211181
application number: ANDA211181
ndc (product): 58657-810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903841pyRIDostigmine bromide 30 MG Oral TabletPSNe756717f-941b-42f2-ba3b-03798c005ae79
903841pyridostigmine bromide 30 MG Oral TabletSCDe756717f-941b-42f2-ba3b-03798c005ae79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-810-105865708101021 BLISTER PACK in 1 CARTON (58657-810-10) > 10 TABLET in 1 BLISTER PACK21 blister pack2019-06-010000-00-00NoNoCurrent
58657-810-215865708102121 TABLET in 1 BOTTLE (58657-810-21) 21 tablet2019-06-010000-00-00NoNoCurrent
58657-810-305865708103030 CARTON in 1 CARTON (58657-810-30) > 3 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK30 carton2019-06-010000-00-00NoNoCurrent