Home NDC 62332-169 clonidine hydrochloride
Product NDC 62332-169
11-digit product format 623320169
Labeler code 62332
Product ID 62332-169_f3d64f9f-6bfb-48e8-aed1-5623415005ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clonidine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA091368
Marketing category ANDA
Marketing start 2026-09-22
Substance CLONIDINE HYDROCHLORIDE
Active strength .05 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091368-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 A091368-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 A091368-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 129 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 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091368-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2011-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091368-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2011-12-06 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
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 clonidine hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .05 mg/1
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62332-169-10 62332016910 100 BLISTER PACK in 1 CARTON (62332-169-10) / 10 TABLET in 1 BLISTER PACK 100 blister pack 2026-09-22 No No Current 62332-169-30 62332016930 30 TABLET in 1 BOTTLE (62332-169-30) 30 tablet 2026-09-22 No No Current 62332-169-31 62332016931 100 TABLET in 1 BOTTLE (62332-169-31) 100 tablet 2026-09-22 No No Current 62332-169-60 62332016960 60 TABLET in 1 BOTTLE (62332-169-60) 60 tablet 2026-09-22 No No Current 62332-169-71 62332016971 500 TABLET in 1 BOTTLE (62332-169-71) 500 tablet 2026-09-22 No No Current 62332-169-91 62332016991 1000 TABLET in 1 BOTTLE (62332-169-91) 1000 tablet 2026-09-22 No No Current