Home NDC 43547-565 Clonidine Hydrochloride
Product NDC 43547-565
11-digit product format 435470565
Labeler code 43547
Product ID 43547-565_d09551ff-dfac-4525-8122-97b4463e98ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA077901
Marketing category ANDA
Marketing start 2023-01-05
Substance CLONIDINE HYDROCHLORIDE
Active strength .1 mg/1
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 1 .
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 A077901-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 A077901-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 A077901-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09
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 · 123 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 2026-02-19 14:30 UTC 2026-02 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 .1 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884173 Internal RxNorm lookup 884185 Internal RxNorm lookup 884189 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 43547-565-10 Clonidine Hydrochloride 100 in 1 BOTTLE, PLASTIC TABLET 100 3 43547-565-11 Clonidine Hydrochloride 1000 in 1 BOTTLE, PLASTIC TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-565 CLONIDINE HYDROCHLORIDE TABLET [SOLCO HEALTHCARE LLC] 3 Current NDC, Legacy NDC, 2 package rows 20230526_2bbfea75-9241-4c3a-84f5-342ccb3cdf16.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 · 3 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 43547-565-10 43547056510 100 TABLET in 1 BOTTLE, PLASTIC (43547-565-10) 100 tablet 2023-01-05 0000-00-00 No No Current 43547-565-11 43547056511 1000 TABLET in 1 BOTTLE, PLASTIC (43547-565-11) 1000 tablet 2023-01-05 0000-00-00 No No Current