FDA.reportPublic FDA data

Pilocarpine Hydrochloride

Product NDC
61314-203
11-digit product format
613140203
Labeler code
61314
Product ID
61314-203_305559df-eb9c-4584-b5c5-0a83505b4bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pilocarpine hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA200890
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-09-30
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
10 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui1000647, 1000862, 1000897

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
61314-203-15Pilocarpine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS18
61314-203-15Pilocarpine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-203-15ML - Milliliter61314-203d1e6401f-362e-4d2e-bc42-4bdd2d1f0b5c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PILOCARPINE HYDROCHLORIDEACTIVE INGREDIENT0WW6D218XJPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
PILOCARPINE HYDROCHLORIDEACTIVE INGREDIENT0WW6D218XJPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
PILOCARPINEACTIVE MOIETY01MI4Q9DI3PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
PILOCARPINEACTIVE MOIETY01MI4Q9DI3PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4PILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RPILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RPILOCARPINE HYDROCHLORIDE SOLUTION [FALCON PHARMACEUTICALS, LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-203PILOCARPINE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]7Current NDC, Legacy NDC, 2 package rows20220630_53fa0b7a-f982-48a7-92c4-6f098683c1ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000647pilocarpine HCl 1 % Ophthalmic SolutionPSN53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000862pilocarpine HCl 2 % Ophthalmic SolutionPSN53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000897pilocarpine HCl 4 % Ophthalmic SolutionPSN53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000647pilocarpine hydrochloride 10 MG/ML Ophthalmic SolutionSCD53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000862pilocarpine hydrochloride 20 MG/ML Ophthalmic SolutionSCD53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000897pilocarpine hydrochloride 40 MG/ML Ophthalmic SolutionSCD53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000647pilocarpine hydrochloride 1 % Ophthalmic SolutionSY53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000862pilocarpine hydrochloride 2 % Ophthalmic SolutionSY53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000897pilocarpine hydrochloride 4 % Ophthalmic SolutionSY53fa0b7a-f982-48a7-92c4-6f098683c1ed8
1000647pilocarpine HCl 1 % Ophthalmic SolutionPSNd2ded29a-448d-4c4a-9307-403836a67da41
1000647pilocarpine hydrochloride 10 MG/ML Ophthalmic SolutionSCDd2ded29a-448d-4c4a-9307-403836a67da41
1000647pilocarpine hydrochloride 1 % Ophthalmic SolutionSYd2ded29a-448d-4c4a-9307-403836a67da41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-203-15613140203151 BOTTLE in 1 CARTON (61314-203-15) / 15 mL in 1 BOTTLE1 bottle2011-09-300000-00-00NoNoCurrent