FDA.reportPublic FDA data

Pilocarpine Hydrochloride

Product NDC
70069-181
11-digit product format
700690181
Labeler code
70069
Product ID
70069-181_82a2d0b0-5ac5-46a1-b945-1f5669cc75ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride Ophthalmic Solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA210384
Marketing category
ANDA
Marketing start
2019-11-25
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
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 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
38c480e0-b6d3-b416-6514-a787406e5176Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-181-01Pilocarpine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS18
70069-181-01Pilocarpine Hydrochloride15 mL in 1 BOTTLESOLUTION/ DROPS158

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-181-01ML - Milliliter70069-1811a4ef293-34fb-40fa-81f1-3a6e7a9ab41212019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-181PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]6Current NDC, Legacy NDC, 2 package rows20230602_84428e9a-f486-44d9-ad93-4ea9069a6787.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000647pilocarpine HCl 1 % Ophthalmic SolutionPSN84428e9a-f486-44d9-ad93-4ea9069a67878
1000862pilocarpine HCl 2 % Ophthalmic SolutionPSN84428e9a-f486-44d9-ad93-4ea9069a67878
1000897pilocarpine HCl 4 % Ophthalmic SolutionPSN84428e9a-f486-44d9-ad93-4ea9069a67878
1000647pilocarpine hydrochloride 10 MG/ML Ophthalmic SolutionSCD84428e9a-f486-44d9-ad93-4ea9069a67878
1000862pilocarpine hydrochloride 20 MG/ML Ophthalmic SolutionSCD84428e9a-f486-44d9-ad93-4ea9069a67878
1000897pilocarpine hydrochloride 40 MG/ML Ophthalmic SolutionSCD84428e9a-f486-44d9-ad93-4ea9069a67878
1000647pilocarpine hydrochloride 1 % Ophthalmic SolutionSY84428e9a-f486-44d9-ad93-4ea9069a67878
1000862pilocarpine hydrochloride 2 % Ophthalmic SolutionSY84428e9a-f486-44d9-ad93-4ea9069a67878
1000897pilocarpine hydrochloride 4 % Ophthalmic SolutionSY84428e9a-f486-44d9-ad93-4ea9069a67878

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-181-01700690181011 BOTTLE in 1 CARTON (70069-181-01) / 15 mL in 1 BOTTLE1 bottle2019-11-250000-00-00NoNoCurrent