Home NDC 46287-085 QLONILIK
Product NDC 46287-085
11-digit product format 462870085
Labeler code 46287
Product ID 46287-085_9d9a0953-57dd-439d-a354-826284f56725
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler CMP Pharma, Inc.
Application NDA221094
Marketing category NDA
Marketing start 2026-08-28
Substance CLONIDINE HYDROCHLORIDE
Active strength .05 mg/mL
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N221094-001 QLONILIK CLONIDINE HYDROCHLORIDE 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-07-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N221094-001 12551466 2045-08-22 U-4581 Drug product 2026-08-03
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 2026-09-14 22:38:34 2026-08 N221094-001 QLONILIK 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-07-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N221094-001 QLONILIK 0.05MG/ML SOLUTION / ORAL RLD, RS 2026-07-29 caaa826d4ba7…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N221094-001 12551466 2045-08-22 U-4581 Drug product 2026-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N221094-001 12551466 2045-08-22 U-4581 Drug product 2026-08-03 caaa826d4ba7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base QLONILIK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .05 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W76I6XXF06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2750198 Internal RxNorm lookup 2750205 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46287-085-04 46287008504 120 mL in 1 BOTTLE (46287-085-04) 120 ml 2026-08-28 No No Current