Home NDC 10544-196 Clonidine Hydrochloride
Product NDC 10544-196
11-digit product format 105440196
Labeler code 10544
Product ID 10544-196_104fea5c-cb2d-16c3-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA077901
Marketing category ANDA
Marketing start 2013-11-15
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 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-196-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-196-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-196-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-196-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-196-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-196-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-196-90 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-196-90 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-196-90 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-196-90 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-196-90 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-196-90 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-196-90 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-196-90 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-196-90 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-196-90 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-196-90 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-196-90 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-196-90 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-196-90 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-196-90 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-196-90 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
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 10544-196-90 Clonidine Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLONIDINE HYDROCHLORIDE ACTIVE INGREDIENT W76I6XXF06 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 CLONIDINE ACTIVE MOIETY MN3L5RMN02 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-196 CLONIDINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.] 2 Legacy NDC, 1 package rows 20150302_104a3cba-6ed9-48b3-e054-00144ff8d46c.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 10544-196-90 10544019690 90 in 1 BOTTLE, PLASTIC Historical