Pryidostigmine Bromide

Product NDC
16571-833
11-digit product format
165710833
Labeler code
16571
Product ID
16571-833_b46177b2-68dc-4958-a4ec-d4bd6d887456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyridostigmine Bromide
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA208797
Marketing category
ANDA
Marketing start
2022-09-15
Substance
PYRIDOSTIGMINE BROMIDE
Active strength
60 mg/5mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOSTIGMINE BROMIDE60 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKVI301NA53
Rxcui903843

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd6f4a37-8abf-2ed8-817f-5becdfa53ca5Product name920230112
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
dd640b44-88ec-4cbe-02c0-23127b95f5d3Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-833-16Pryidostigmine Bromide473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-833-16ML - Milliliter16571-833dd450e30-213c-464f-8f54-86ca52796e2612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-833PRYIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) SOLUTION [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 1 package rows20220915_beda905e-005a-439d-ac74-92db4e269780.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903843pyRIDostigmine bromide 60 MG in 5 mL Oral SolutionPSNbeda905e-005a-439d-ac74-92db4e2697801
903843pyridostigmine bromide 12 MG/ML Oral SolutionSCDbeda905e-005a-439d-ac74-92db4e2697801
903843pyridostigmine bromide 60 MG per 5 ML Oral SolutionSYbeda905e-005a-439d-ac74-92db4e2697801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-833-1616571083316473 mL in 1 BOTTLE, PLASTIC (16571-833-16) 473 ml2022-09-150000-00-00NoNoCurrent