Home NDC 0378-0186 Clonidine Hydrochloride
Product NDC 0378-0186
11-digit product format 003780186
Labeler code 0378
Product ID 0378-0186_c16087c0-cf3a-46c3-8151-81895c298888
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA070317
Marketing category ANDA
Marketing start 1987-06-09
Marketing end 2020-09-30
Substance CLONIDINE HYDROCHLORIDE
Active strength 0 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A070317-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 A070317-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 A070317-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09
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 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070317-002 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL 1987-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070317-003 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL 1987-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070317-001 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL 1987-06-09 8072bd15b7f6…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed RxNorm Mappings#