Clonidine Hydrochloride

Product NDC
0615-2574
11-digit product format
006152574
Labeler code
0615
Product ID
0615-2574_69be47b6-270c-4e24-9352-560a5b5b250f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA070976
Marketing category
ANDA
Marketing start
1995-01-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-2574DDiscontinued by firm2026-08-03
excluded packagepackage0615-25740615-2574-39DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-2574-39d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-2574-39f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-2574-392ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-2574-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-2574-39cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-2574-39cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-2574-39302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-2574-39ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-2574-390efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-2574-39ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-2574-39367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-2574-39557ba5c1ecfa…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
A070976-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / 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
A070976-001AB

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 UTC2026-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB1986-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070976-001CLONIDINE HYDROCHLORIDE0.3MGTABLET / 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 UTC2026-02A070976-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070976-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070976-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070976-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070976-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070976-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070976-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070976-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070976-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070976-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070976-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070976-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070976-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070976-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070976-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070976-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070976-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070976-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070976-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070976-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070976-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070976-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070976-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070976-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070976-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070976-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070976-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070976-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070976-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070976-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070976-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070976-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070976-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070976-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070976-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070976-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070976-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070976-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070976-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070976-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W76I6XXF06Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
acdddd91-ffe3-4b9b-9c59-0328e018b662Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-2574-39Clonidine Hydrochloride30 in 1 BLISTER PACKTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-2574CLONIDINE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]7Current NDC, Legacy NDC, 1 package rows20240815_acdddd91-ffe3-4b9b-9c59-0328e018b662.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEBluePoint Laboratories1ea412db-d847-4094-be83-e3bd7328537a2025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsacdddd91-ffe3-4b9b-9c59-0328e018b6622024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
ndc (product): 0615-2574
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEActavis Pharma, Inc.a842ab83-3531-44dd-a8a8-64dd89e870262022-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCe9b22c56-a3fc-46df-b745-11c4ac309a912017-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070976
application number: ANDA070976

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884189cloNIDine HCl 0.3 MG Oral TabletPSNacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine hydrochloride 0.3 MG Oral TabletSCDacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine HCl 300 MCG Oral TabletSYacdddd91-ffe3-4b9b-9c59-0328e018b6627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-2574-390061525743930 TABLET in 1 BLISTER PACK (0615-2574-39) 30 tablet2019-02-070000-00-00NoNoCurrent