Clonidine Hydrochloride

Product NDC
0904-5656
Requested package NDC
0904-5656-61
11-digit product format
009045656
Labeler code
0904
Product ID
0904-5656_e6c8545d-096f-47b8-bf52-caba27616ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA070974
Marketing category
ANDA
Marketing start
2006-11-20
Marketing end
2021-03-31
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-56560904-5656-61DDiscontinued by firm2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070974-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A070974-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070974-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB1986-12-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070974-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070974-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070974-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070974-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070974-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070974-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070974-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070974-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070974-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070974-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070974-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070974-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070974-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070974-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070974-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070974-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070974-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070974-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070974-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070974-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070974-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070974-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070974-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070974-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070974-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070974-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070974-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070974-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070974-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070974-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070974-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070974-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070974-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070974-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070974-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070974-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070974-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070974-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070974-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070974-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5656-61EA - Each0904-565698fd3d1f-6b50-413f-9c5b-ec26b3f1daca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]9
Clonidine HydrochlorideACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [GENERAL INJECTABLES & VACCINES, INC]4
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
ClonidineACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE (CLONIDINE HYDROCHLORIDE) TABLET [GENERAL INJECTABLES & VACCINES, INC]4
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]4

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.7ec53e25-c50a-48b4-82b0-c0b3626f31dc2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDECardinal Health 107, LLCdf62817d-2f50-4c27-aaa8-a22f0290c94f2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLC66dc3cf0-d6bd-436c-9a7f-7477575b32602026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEBluePoint Laboratories1ea412db-d847-4094-be83-e3bd7328537a2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.00c6d67a-bb11-4884-9eeb-4e1b8701a08b2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df4b087e-a81a-1321-e053-2995a90a2b9f2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cd64137-09d7-7a00-e053-2a91aa0a06ae2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs0bde4636-7f34-467e-b9b9-8d281145177d2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAmerican Health Packagingb4733c99-656d-4049-9422-3732492dd6ed2024-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEActavis Pharma, Inc.a842ab83-3531-44dd-a8a8-64dd89e870262022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070974
application number: ANDA070974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5656-6100904565661100 BLISTER PACK in 1 CARTON (0904-5656-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2006-11-202021-03-31NoNoCurrent