FDA.reportPublic FDA data

Pilocarpine Hydrochloride Ophthalmic

Product NDC
60219-2366
11-digit product format
602192366
Labeler code
60219
Product ID
60219-2366_a804f045-c81b-469d-848d-475bf8aac237
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217733
Marketing category
ANDA
Marketing start
2025-05-01
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
12.5 mg/mL
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 Ophthalmic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE12.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui2584552

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
60219-2366-2Pilocarpine Hydrochloride Ophthalmic2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.56
60219-2366-2Pilocarpine Hydrochloride Ophthalmic1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2366-2ML - Milliliter60219-23668d2cd660-2a19-48ec-a705-efaec6ad887d12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2366PILOCARPINE HYDROCHLORIDE OPHTHALMIC (PILOCARPINE HYDROCHLORIDE) SOLUTION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, 2 package rows20250503_93e37b61-7b90-4740-b0b4-17d39d3b03f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2584552pilocarpine HCl 1.25 % Ophthalmic SolutionPSN93e37b61-7b90-4740-b0b4-17d39d3b03f66
2584552pilocarpine hydrochloride 12.5 MG/ML Ophthalmic SolutionSCD93e37b61-7b90-4740-b0b4-17d39d3b03f66
2584552pilocarpine hydrochloride 1.25 % Ophthalmic SolutionSY93e37b61-7b90-4740-b0b4-17d39d3b03f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-2366-2602192366021 BOTTLE, DROPPER in 1 CARTON (60219-2366-2) / 2.5 mL in 1 BOTTLE, DROPPER2025-05-01NoNoCurrent