Pilocarpine Hydrochloride

Product NDC
0115-5911
11-digit product format
001155911
Labeler code
0115
Product ID
0115-5911_6623703f-52d6-48ad-881b-2d20d4c0989d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PILOCARPINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077248
Marketing category
ANDA
Marketing start
2007-05-01
Marketing end
0000-00-00
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA],Cholinergic Muscarinic Agonists [MoA],Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-5911-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10014
0115-5911-03Pilocarpine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-5911-01EA - Each0115-5911832c110d-6c7d-4d82-a062-77d34bd119dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PILOCARPINE HYDROCHLORIDEACTIVE INGREDIENT0WW6D218XJPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
PILOCARPINEACTIVE MOIETY01MI4Q9DI3PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-5911PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]14Legacy NDC, 2 package rows20201230_3a0de319-5390-426c-9c71-76acc03735c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN3a0de319-5390-426c-9c71-76acc03735c714
1001004pilocarpine HCl 7.5 MG Oral TabletPSN3a0de319-5390-426c-9c71-76acc03735c714
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD3a0de319-5390-426c-9c71-76acc03735c714
1001004pilocarpine hydrochloride 7.5 MG Oral TabletSCD3a0de319-5390-426c-9c71-76acc03735c714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-5911-0100115591101100 TABLET, FILM COATED in 1 BOTTLE (0115-5911-01) 2007-05-010000-00-00NoNoCurrent
0115-5911-03001155911031000 TABLET, FILM COATED in 1 BOTTLE (0115-5911-03) 2007-05-010000-00-00NoNoCurrent