FDA.reportPublic FDA data

Pilocarpine Hydrochloride

Product NDC
50268-652
11-digit product format
502680652
Labeler code
50268
Product ID
50268-652_47fb4499-fabd-6354-e063-6394a90a8c41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA077220
Marketing category
ANDA
Marketing start
2021-01-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pilocarpine Hydrochloride
Listing expiration
2027-12-31

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
50268-652-11Pilocarpine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED14
50268-652-12Pilocarpine Hydrochloride20 in 1 BOXTABLET, FILM COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-652-11EA - Each50268-65227bd8cb7-14d7-4246-ab8f-42eb648a973712021-02-05
50268-652-12EA - Each50268-652c06977fa-ad17-4d8c-ba29-56fb8eabbfc912021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-652PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]3Current NDC, Legacy NDC, 2 package rows20221116_b85547d8-fcec-323d-e053-2995a90a4e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSNb85547d8-fcec-323d-e053-2995a90a4e7e4
1000913pilocarpine hydrochloride 5 MG Oral TabletSCDb85547d8-fcec-323d-e053-2995a90a4e7e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-652-11502680652111 in 1 BLISTER PACKHistorical
50268-652-125026806521220 BLISTER PACK in 1 BOX (50268-652-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-652-11) 20 blister pack2021-01-070000-00-00NoNoCurrent