FDA.reportPublic FDA data

Qlosi

Product NDC
83661-018
11-digit product format
836610018
Labeler code
83661
Product ID
83661-018_35bee113-ab9f-605d-e063-6394a90ac5a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pilocarpine Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Orasis Pharmaceuticals, Inc.
Application
NDA217836
Marketing category
NDA
Marketing start
2024-10-15
Substance
PILOCARPINE HYDROCHLORIDE
Active strength
4 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
Qlosi
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PILOCARPINE HYDROCHLORIDE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WW6D218XJ
Rxcui2695439, 2695445

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
83661-018-10Qlosi0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.45
83661-018-10Qlosi10 in 1 BOXSOLUTION105
83661-018-20Qlosi0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.45
83661-018-20Qlosi20 in 1 BOXSOLUTION205
83661-018-30Qlosi30 in 1 BOXSOLUTION305
83661-018-30Qlosi0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.45
83661-018-60Qlosi0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.45
83661-018-60Qlosi60 in 1 BOXSOLUTION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83661-018-30EA - Each83661-0183b3b34e3-e7a6-477c-94ce-eed69d89fe0a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83661-018QLOSI (PILOCARPINE HYDROCHLORIDE) SOLUTION [ORASIS PHARMACEUTICALS, INC.]4Current NDC, 8 package rows20250417_4ee2a840-1203-473a-aa42-316a3ddf2fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695439pilocarpine hydrochloride 0.4 % Ophthalmic SolutionPSN4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695445Qlosi 0.4 % Ophthalmic SolutionPSN4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695445pilocarpine hydrochloride 4 MG/ML Ophthalmic Solution [Qlosi]SBD4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695439pilocarpine hydrochloride 4 MG/ML Ophthalmic SolutionSCD4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695439pilocarpine hydrochloride 0.4 % Ophthalmic SolutionSY4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695445Qlosi 0.4 % Ophthalmic SolutionSY4ee2a840-1203-473a-aa42-316a3ddf2fbe5
2695445Qlosi 4 MG/ML Ophthalmic SolutionSY4ee2a840-1203-473a-aa42-316a3ddf2fbe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83661-018-108366100181010 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USE2025-01-15NoNoHistorical
83661-018-208366100182020 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USE2025-01-15NoNoHistorical
83661-018-308366100183030 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE2024-10-15NoNoHistorical
83661-018-608366100186060 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USE2025-01-15NoNoHistorical