Home NDC 66336-786 Clonidine Hydrochloride
Product NDC 66336-786
11-digit product format 663360786
Labeler code 66336
Product ID 66336-786_bdaaa82c-2eae-48cb-832f-4a7f4b2c1fd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
Application ANDA077901
Marketing category ANDA
Marketing start 2007-03-09
Marketing end 0000-00-00
Substance CLONIDINE HYDROCHLORIDE
Active strength 0 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077901-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2007-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077901-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2007-03-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077901-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB 2007-03-09 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 4 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66336-786-12 Clonidine Hydrochloride 12 in 1 BOTTLE, PLASTIC TABLET 12 2 66336-786-94 Clonidine Hydrochloride 120 in 1 BOTTLE, PLASTIC TABLET 120 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLONIDINE HYDROCHLORIDE ACTIVE INGREDIENT W76I6XXF06 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 CLONIDINE ACTIVE MOIETY MN3L5RMN02 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-786 CLONIDINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.] 2 Legacy NDC, 2 package rows 20130820_defc0e8b-6ffd-43f9-a88d-5c4afb2b8060.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 Status 66336-786-12 66336078612 12 in 1 BOTTLE, PLASTIC Historical 66336-786-94 66336078694 120 in 1 BOTTLE, PLASTIC Historical