Home DailyMed d2b11e61-b2ef-4d20-8973-a4afc6b951ae Clonidine Hydrochloride Injection Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer Zydus Lifesciences Limited
Effective date 2021-11-29
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 5
Source legacy-cache
Hydrated at 2026-08-01 21:51:24 Label at a glance# Product clonidine hydrochloride
Active ingredient CLONIDINE HYDROCHLORIDE
Label structure 1 sections
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1193 CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] 5 Legacy NDC 20221019_d2b11e61-b2ef-4d20-8973-a4afc6b951ae.zip 70771-1194 CLONIDINE HYDROCHLORIDE INJECTION, SOLUTION [ZYDUS LIFESCIENCES LIMITED] 5 Legacy NDC 20221019_d2b11e61-b2ef-4d20-8973-a4afc6b951ae.zip
Products# Every source-derived product name is available through these pages.
DailyMed product names page 1 of 1 · 3 matching rows.
clonidine hydrochloride CLONIDINE SODIUM CHLORIDE Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 1 · 4 matching rows.
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202601-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 A202601-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20
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 · 86 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 2026-09-14 22:38:34 2026-08 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202601-001 CLONIDINE HYDROCHLORIDE 1MG/10ML (0.1MG/ML) INJECTABLE / INJECTION AP 2014-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202601-002 CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE / INJECTION AP 2014-02-20 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
