clonidine hydrochloride

Product NDC
68071-4094
Requested package NDC
68071-4094-1
11-digit product format
680714094
Labeler code
68071
Product ID
68071-4094_bb2cb8c2-5acc-67fb-e053-2a95a90ad1fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078895
Marketing category
ANDA
Marketing start
2009-09-21
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
No
Listing certified through
2022-12-31
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 packagepackage68071-409468071-4094-1DDiscontinued by firm2026-08-17

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078895-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26
A078895-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26
A078895-003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A078895-001AB
A078895-002AB
A078895-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-261e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078895-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078895-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078895-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078895-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078895-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078895-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078895-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078895-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078895-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078895-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078895-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078895-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078895-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078895-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078895-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078895-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078895-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e5d24f52-e0c2-428d-b647-481d63ffd95f2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e96ab74c-eedf-4d71-8a35-d5ec3daa75922026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy32d72d7b-5881-f431-e063-6394a90a35472026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ea1527a5-4939-4ff7-a827-f88a9113a07d2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be1b921d-152e-4bd5-82bd-56e2f8beef3e2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEASCLEMED USA INC.200afa03-adf3-4dca-8de8-1569701bd0292026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.55ab721b-7b4c-42d5-99e3-745008fe139c2026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.21bfa28f-20df-43fd-bb80-b720d3b406962026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1ab3b82f-db7f-22bf-e063-6294a90ae93f2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLCab2ffb6e-7070-063b-e053-2a95a90aff222026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEVERITYRX, LLC427939a4-6bbf-0d80-e063-6294a90aa2a02025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDERedpharm Drug300b4437-74b3-119b-e063-6394a90a0d0f2025-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAvPAKfcebe343-18ad-d4cd-e053-6294a90a72d52025-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutionsc5c85b76-4d5c-47f0-bafb-31efe1fbaed32024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutions9d889b1c-9599-44fa-9e47-6261fbf2837e2024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutions70c0c9f4-075d-4621-ae13-e8f03d814d5f2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.415b168c-1267-2777-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutions22fbd302-46b5-4bdc-87e2-fda94cb225302024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepack893a6cf5-d34e-4971-b132-3f5138e481ce2023-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP38680c1d-3929-40d5-bda9-4eea5693afca2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078895
application number: ANDA078895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4094-168071409401100 TABLET in 1 BOTTLE (68071-4094-1) 100 tablet2017-09-120000-00-00NoNoCurrent