qlosi

Generic: pilocarpine hydrochloride

Labeler: orasis pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name qlosi
Generic Name pilocarpine hydrochloride
Labeler orasis pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

pilocarpine hydrochloride 4 mg/mL

Manufacturer
Orasis Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 83661-018
Product ID 83661-018_35bee113-ab9f-605d-e063-6394a90ac5a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217836
Listing Expiration 2026-12-31
Marketing Start 2024-10-15

Pharmacologic Class

Classes
cholinergic agonists [moa] cholinergic muscarinic agonists [moa] cholinergic receptor agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83661018
Hyphenated Format 83661-018

Supplemental Identifiers

RxCUI
2695439 2695445
UPC
0383661018301
UNII
0WW6D218XJ

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name qlosi (source: ndc)
Generic Name pilocarpine hydrochloride (source: ndc)
Application Number NDA217836 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USE
  • 20 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USE
  • 30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE
  • 60 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (4)

83661-018-10 10 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USE 83661-018-20 20 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USE 83661-018-30 30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE 83661-018-60 60 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

pilocarpine hydrochloride (4 mg/mL)

Linked Drug Pages (1)

Qlosi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "35bee113-ab9f-605d-e063-6394a90ac5a2", "openfda": {"upc": ["0383661018301"], "unii": ["0WW6D218XJ"], "rxcui": ["2695439", "2695445"], "spl_set_id": ["4ee2a840-1203-473a-aa42-316a3ddf2fbe"], "manufacturer_name": ["Orasis Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 BOX (83661-018-10)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83661-018-10", "marketing_start_date": "20250115"}, {"sample": false, "description": "20 VIAL, SINGLE-USE in 1 BOX (83661-018-20)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83661-018-20", "marketing_start_date": "20250115"}, {"sample": false, "description": "30 VIAL, SINGLE-USE in 1 BOX (83661-018-30)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83661-018-30", "marketing_start_date": "20241015"}, {"sample": false, "description": "60 VIAL, SINGLE-USE in 1 BOX (83661-018-60)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83661-018-60", "marketing_start_date": "20250115"}], "brand_name": "Qlosi", "product_id": "83661-018_35bee113-ab9f-605d-e063-6394a90ac5a2", "dosage_form": "SOLUTION", "pharm_class": ["Cholinergic Agonists [MoA]", "Cholinergic Muscarinic Agonists [MoA]", "Cholinergic Receptor Agonist [EPC]"], "product_ndc": "83661-018", "generic_name": "Pilocarpine Hydrochloride", "labeler_name": "Orasis Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qlosi", "active_ingredients": [{"name": "PILOCARPINE HYDROCHLORIDE", "strength": "4 mg/mL"}], "application_number": "NDA217836", "marketing_category": "NDA", "marketing_start_date": "20241015", "listing_expiration_date": "20261231"}