Home NDC 83661-018 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217836-001 QLOSI PILOCARPINE HYDROCHLORIDE 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217836-001 NP 2026-10-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217836-001 QLOSI 0.4% SOLUTION / OPHTHALMIC RLD, RS 2023-10-17 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217836-001 QLOSI 0.4% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2023-10-17 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217836-001 10639297 2037-08-18 U-3741 Drug product 2023-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 11129812 2037-08-18 U-3741 2023-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 11974986 2037-08-18 U-3741 2024-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217836-001 9867810 2037-08-18 U-3741 Drug product 2023-11-14 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Qlosi
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PILOCARPINE HYDROCHLORIDE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0WW6D218XJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2695439 Internal RxNorm lookup 2695445 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83661-018 QLOSI (PILOCARPINE HYDROCHLORIDE) SOLUTION [ORASIS PHARMACEUTICALS, INC.] 4 Current NDC, 8 package rows 20250417_4ee2a840-1203-473a-aa42-316a3ddf2fbe.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Qlosi PILOCARPINE HYDROCHLORIDE Orasis Pharmaceuticals, Inc. 4ee2a840-1203-473a-aa42-316a3ddf2fbe 2025-05-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 217836 application number: NDA217836 ndc (product): 83661-018
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83661-018-10 83661001810 10 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USE 2025-01-15 No No Current 83661-018-20 83661001820 20 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USE 2025-01-15 No No Current 83661-018-30 83661001830 30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USE 2024-10-15 No No Current 83661-018-60 83661001860 60 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USE 2025-01-15 No No Current