Pilocarpine Hydrochloride

Product NDC
69292-265
11-digit product format
692920265
Labeler code
69292
Product ID
69292-265_e96671e2-f7a8-4d58-8b7f-35b9b7fab5a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PILOCARPINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AMICI PHARMACEUTICALS LLC
Application
ANDA076963
Marketing category
ANDA
Marketing start
2022-07-26
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
69292-265-01Pilocarpine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69292-265-01EA - Each69292-2659728bd07-77ae-4f37-a201-1827985f613612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-265PILOCARPINE HYDROCHLORIDE TABLET, FILM COATED [AMICI PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 1 package rows20220730_a86a7b63-5f6a-4c10-9270-24c7b7d50437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000913pilocarpine HCl 5 MG Oral TabletPSNa86a7b63-5f6a-4c10-9270-24c7b7d504373
1000913pilocarpine hydrochloride 5 MG Oral TabletSCDa86a7b63-5f6a-4c10-9270-24c7b7d504373

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69292-265-0169292026501100 TABLET, FILM COATED in 1 BOTTLE (69292-265-01) 2022-07-260000-00-00NoNoCurrent