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

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 Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui2695047

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

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