clonidine hydrochloride

Product NDC
67296-2120
11-digit product format
672962120
Labeler code
67296
Product ID
67296-2120_3d92daa2-02d9-a413-e063-6294a90a7dd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA078895
Marketing category
ANDA
Marketing start
2020-12-24
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 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

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-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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078895-001CLONIDINE 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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2009-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALABRS2009-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078895-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2009-08-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078895-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078895-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.1 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
884173Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
300b4437-74b3-119b-e063-6394a90a0d0fAvailable 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
67296-2120-1clonidine hydrochloride500 in 1 BOTTLE, PLASTICTABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2120CLONIDINE HYDROCHLORIDE TABLET [REDPHARM DRUG]1Current NDC, 1 package rows20250312_300b4437-74b3-119b-e063-6394a90a0d0f.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 HYDROCHLORIDEREMEDYREPACK INC.e5d24f52-e0c2-428d-b647-481d63ffd95f2026-04-06Warnings, 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
ndc (product): 67296-2120
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSN300b4437-74b3-119b-e063-6394a90a0d0f2
884173clonidine hydrochloride 0.1 MG Oral TabletSCD300b4437-74b3-119b-e063-6394a90a0d0f2
884173clonidine HCl 100 MCG Oral TabletSY300b4437-74b3-119b-e063-6394a90a0d0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2120-167296212001500 TABLET in 1 BOTTLE, PLASTIC (67296-2120-1) 500 tablet2020-12-24NoNoCurrent