FDA.reportPublic FDA data

Pyridostigmine bromide

Product NDC
60846-559
11-digit product format
608460559
Labeler code
60846
Product ID
60846-559_d6813c89-ca7b-4495-86ac-137a38854371
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine bromide
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA217604
Marketing category
NDA
Marketing start
2024-10-09
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
105 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
N217604-001PYRIDOSTIGMINE BROMIDEPYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217604-001108816172038-06-18Drug product2024-10-23
N217604-001109258332038-06-18Drug product2024-10-23
N217604-001109873112038-06-18Drug product2024-10-23
N217604-001112296062038-06-18Drug product2024-10-23
N217604-001114784252038-06-18U-4012Drug product2024-10-23
N217604-001116665362038-06-18Drug product2024-10-23
N217604-001119115152038-06-18Drug product2024-10-23
N217604-001120425592038-06-18Drug product2024-10-23
N217604-001122331662038-06-18Drug product2025-03-17

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-042680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04d8e5a09893c0…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217604-001PYRIDOSTIGMINE BROMIDE105MGTABLET, EXTENDED RELEASE / ORAL2024-10-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N217604-001108816172038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001109258332038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001109873112038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001112296062038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001114784252038-06-18U-4012Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001116665362038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001119115152038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001120425592038-06-18Drug product2024-10-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217604-001122331662038-06-18Drug product2025-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001108816172038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001109258332038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001109873112038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001112296062038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001114784252038-06-18U-4012Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001116665362038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001119115152038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001120425592038-06-18Drug product2024-10-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217604-001122331662038-06-18Drug product2025-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N217604-001108816172038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001109258332038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001109873112038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001112296062038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001114784252038-06-18U-4012Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001116665362038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001119115152038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001120425592038-06-18Drug product2024-10-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217604-001122331662038-06-18Drug product2025-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001108816172038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001109258332038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001109873112038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001112296062038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001114784252038-06-18U-4012Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001116665362038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001119115152038-06-18Drug product2024-10-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217604-001120425592038-06-18Drug product2024-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001108816172038-06-18Drug product2024-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001109258332038-06-18Drug product2024-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001109873112038-06-18Drug product2024-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001112296062038-06-18Drug product2024-10-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217604-001114784252038-06-18U-4012Drug product2024-10-23b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Pyridostigmine bromide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE105 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
2695047Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52d6f195-165a-400b-a13b-489e94bcf0b0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60846-559-10Pyridostigmine bromide10 in 1 BAGTABLET, EXTENDED RELEASE108
60846-559-27Pyridostigmine bromide1 in 1 CARTONTABLET, EXTENDED RELEASE18
60846-559-27Pyridostigmine bromide7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60846-559-10EA - Each60846-559a23c99d6-dee2-495d-b38c-3c1a8c2f8e4e12024-12-10
60846-559-27EA - Each60846-5592b2abd74-9660-4feb-b506-7b24c6eb7b9b12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60846-559PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]2Current NDC, 3 package rows20241013_52d6f195-165a-400b-a13b-489e94bcf0b0.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
Pyridostigmine bromidePYRIDOSTIGMINE BROMIDEAmneal Pharmaceuticals LLC52d6f195-165a-400b-a13b-489e94bcf0b02026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 217604
application number: NDA217604
ndc (product): 60846-559

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695047pyRIDostigmine bromide 105 MG 24HR Extended Release Oral TabletPSN52d6f195-165a-400b-a13b-489e94bcf0b08
269504724 HR pyridostigmine bromide 105 MG Extended Release Oral TabletSCD52d6f195-165a-400b-a13b-489e94bcf0b08
2695047pyridostigmine bromide 105 MG (equivalent to pyridostigmine 72.87 MG) 24 HR Extended Release Oral TabletSY52d6f195-165a-400b-a13b-489e94bcf0b08
2695047pyridostigmine bromide 105 MG 24 HR Extended Release Oral TabletSY52d6f195-165a-400b-a13b-489e94bcf0b08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60846-559-106084605591010 CARTON in 1 BAG (60846-559-10) / 1 BLISTER PACK in 1 CARTON (60846-559-27) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 carton2024-10-09NoNoCurrent
60846-559-27608460559271 in 1 CARTONHistorical