Pilocarpine Hydrochloride

Product NDC
63629-8351
11-digit product format
636298351
Labeler code
63629
Product ID
63629-8351_be3bf41c-ed8c-420a-a9c4-72e3e9e1c869
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077220
Marketing category
ANDA
Marketing start
2005-10-14
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pilocarpine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui1000913

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92fc48b4-3815-4611-a8be-f74b29f9b350Product name220260130
c8f45a17-34ae-46eb-871b-470615085910Product name120250630
dad00d81-2cbe-bbab-dd06-a12043b5e56dProduct name420210512
419b812f-d1a6-2de2-5dee-bec68d6ec699Product name220200123
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8351-1Pilocarpine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8351PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, Legacy NDC, 1 package rows20241220_fb97323d-acec-4e4a-af16-efef66d969dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSNfb97323d-acec-4e4a-af16-efef66d969dc2
1000913pilocarpine hydrochloride 5 MG Oral TabletSCDfb97323d-acec-4e4a-af16-efef66d969dc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8351-16362983510130 TABLET, FILM COATED in 1 BOTTLE (63629-8351-1) 2020-09-020000-00-00NoNoCurrent