Pilocarpine Hydrochloride

Product NDC
59651-224
11-digit product format
596510224
Labeler code
59651
Product ID
59651-224_43f023b3-346b-4b93-95b9-ded7f37da9be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pilocarpine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212377
Marketing category
ANDA
Marketing start
2019-08-13
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
59651-224-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-224-01EA - Each59651-224cbea4e32-eede-4920-a6c5-b3ec0750384912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-224PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 1 package rows20210501_438cfaa3-b5f6-4d75-ac22-b0b4e07bb118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSN438cfaa3-b5f6-4d75-ac22-b0b4e07bb1185
1001004pilocarpine HCl 7.5 MG Oral TabletPSN438cfaa3-b5f6-4d75-ac22-b0b4e07bb1185
1000913pilocarpine hydrochloride 5 MG Oral TabletSCD438cfaa3-b5f6-4d75-ac22-b0b4e07bb1185
1001004pilocarpine hydrochloride 7.5 MG Oral TabletSCD438cfaa3-b5f6-4d75-ac22-b0b4e07bb1185

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-224-0159651022401100 TABLET, FILM COATED in 1 BOTTLE (59651-224-01) 2019-08-130000-00-00NoNoCurrent