Home NDC 39822-2010 Clonidine
Product NDC 39822-2010
11-digit product format 398222010
Labeler code 39822
Product ID 39822-2010_103027a7-2f0d-8d8c-e063-6294a90aedc7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonidine
Dosage form INJECTION, SOLUTION
Route EPIDURAL
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA203167
Marketing category ANDA
Marketing start 2013-10-29
Substance CLONIDINE HYDROCHLORIDE
Active strength 500 ug/mL
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic 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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203167-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 A203167-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203167-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2013-10-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203167-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2013-10-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clonidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE 500 ug/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 884221 Internal RxNorm lookup 884225 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 39822-2010-1 Clonidine 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 14
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-2010 CLONIDINE INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240202_ada02f1f-ae78-4435-879e-492ae862d504.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 39822-2010-1 39822201001 10 mL in 1 VIAL, SINGLE-DOSE (39822-2010-1) 10 ml 2013-10-29 0000-00-00 No No Current