FDA.reportPublic FDA data

Pilocarpine hydrochloride

Product NDC
0228-2801
11-digit product format
002282801
Labeler code
0228
Product ID
0228-2801_7db72b88-d664-4f26-901c-46c901b20d80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA020237
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-09-13
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, 1001004

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
0228-2801-11Pilocarpine hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2801-11EA - Each0228-28012fdfa09c-4265-4354-bda0-cc6efbcde75d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PILOCARPINE HYDROCHLORIDEACTIVE INGREDIENT0WW6D218XJPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
PILOCARPINEACTIVE MOIETY01MI4Q9DI3PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]5
PILOCARPINE HYDROCHLORIDEACTIVE INGREDIENT0WW6D218XJPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
PILOCARPINEACTIVE MOIETY01MI4Q9DI3PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2801PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 1 package rows20220215_610022b7-7dc9-405a-a580-104657f43bdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN610022b7-7dc9-405a-a580-104657f43bdf10
1001004pilocarpine HCl 7.5 MG Oral TabletPSN610022b7-7dc9-405a-a580-104657f43bdf10
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD610022b7-7dc9-405a-a580-104657f43bdf10
1001004pilocarpine hydrochloride 7.5 MG Oral TabletSCD610022b7-7dc9-405a-a580-104657f43bdf10
1000913pilocarpine HCl 5 MG Oral TabletPSN6f950741-fd3f-4bf7-83b0-f5aa9dbceb768
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD6f950741-fd3f-4bf7-83b0-f5aa9dbceb768
1000913pilocarpine HCl 5 MG Oral TabletPSN75fb8a60-bdba-4805-9c32-94377d1eb67f3
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD75fb8a60-bdba-4805-9c32-94377d1eb67f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2801-1100228280111100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0228-2801-11) 2011-09-130000-00-00NoNoCurrent