Pyridostigmine Bromide

Product NDC
0115-1404
11-digit product format
001151404
Labeler code
0115
Product ID
0115-1404_cb2d3ee1-aeda-4c2c-85d2-3ff7d2de5689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOSTIGMINE BROMIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA203184
Marketing category
ANDA
Marketing start
2015-09-18
Marketing end
0000-00-00
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
180 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct0115-1404IInactivated by FDA2026-08-11
excluded packagepackage0115-14040115-1404-08IInactivated by FDA2026-08-11

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 · 30 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 packagepackage0115-1404-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0115-1404-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0115-1404-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0115-1404-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0115-1404-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0115-1404-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0115-1404-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0115-1404-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0115-1404-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1404-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1404-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1404-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage0115-1404-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage0115-1404-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage0115-1404-081332a3947898…d4bfe170f9cd…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203184-001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORAL2015-09-15

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORAL2015-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-153f01610625f2…
2019-09-15 20:21 UTC2019-09A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203184-001PYRIDOSTIGMINE BROMIDE180MGTABLET, EXTENDED RELEASE / ORALAB2015-09-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203184-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203184-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203184-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203184-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203184-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203184-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203184-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203184-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203184-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203184-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203184-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203184-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203184-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203184-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203184-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203184-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203184-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203184-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203184-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203184-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203184-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203184-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203184-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203184-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203184-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203184-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203184-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203184-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203184-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203184-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203184-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203184-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203184-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203184-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203184-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203184-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203184-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203184-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203184-001AB1cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0115-1404-082024-01-30C16284748780-11030e365-3efc-111a-e063-dadaa90a10e2Pyridostigmine Bromide Extended-Release Tablets (180 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1404-08Pyridostigmine Bromide30 in 1 BOTTLETABLET, EXTENDED RELEASE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1404-08EA - Each0115-1404562916df-f4fb-490e-8b1d-ebcc2b76ce8412015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1404PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Legacy NDC, 1 package rows20201230_013a6524-6eb9-4dbf-b29c-9aec2f40d2d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903847pyRIDostigmine bromide 180 MG Extended Release Oral TabletPSN013a6524-6eb9-4dbf-b29c-9aec2f40d2d013
903847pyridostigmine bromide 180 MG Extended Release Oral TabletSCD013a6524-6eb9-4dbf-b29c-9aec2f40d2d013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-1404-080011514040830 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1404-08) 2015-09-180000-00-00NoNoCurrent