Home NDC 0143-9723 Clonidine Hydrochloride
Product NDC 0143-9723
11-digit product format 001439723
Labeler code 0143
Product ID 0143-9723_9d6244d1-5e85-4da3-b06c-f4fe8da1b6fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonidine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA200300
Marketing category ANDA
Marketing start 2011-01-01
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 A200300-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 A200300-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26
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 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2011-01-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200300-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2011-01-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200300-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP RS 2011-01-26 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 Hydrochloride
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 0143-9723-01 Clonidine Hydrochloride 10 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 10 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9723 CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 4 Current NDC, Legacy NDC, 1 package rows 20220702_2a5b46ec-4c16-48a5-9e58-8d28a3f21274.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 · 2 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 0143-9723-01 00143972301 10 mL in 1 VIAL, SINGLE-USE (0143-9723-01) 10 ml 2011-01-01 0000-00-00 No No Current