FDA.reportPublic FDA data

clonidine hydrochloride

Product NDC
67296-2260
Requested package NDC
67296-2260-1
11-digit product format
672962260
Labeler code
67296
Product ID
67296-2260_53df2c01-4e1c-72f4-e063-6294a90af059
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA091368
Marketing category
ANDA
Marketing start
2016-05-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA]; Central alpha-2 Adrenergic Agonist [EPC]
Listing certified through
2027-12-31
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
A091368-001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2011-12-06
A091368-002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2011-12-06
A091368-003CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB2011-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091368-001AB
A091368-002AB
A091368-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091368-001CLONIDINE HYDROCHLORIDE0.1MGTABLET / ORALAB2011-12-06a50c72e98297…
2026-08-01 22:54:322026-06A091368-002CLONIDINE HYDROCHLORIDE0.2MGTABLET / ORALAB2011-12-06a50c72e98297…
2026-08-01 22:54:322026-06A091368-003CLONIDINE HYDROCHLORIDE0.3MGTABLET / ORALAB2011-12-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091368-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091368-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091368-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.574640a5-829d-4e9d-be32-832a48cbd8dd2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.2a183d05-5be7-43e9-a084-700ec05d01e92026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDERedpharm Drug53df40e7-dd2b-d40e-e063-6394a90a21c42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
ndc (package): 67296-2260-1
ndc (product): 67296-2260
ndc11 (package): 67296226001
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy666e757e-9b43-2e40-e053-2991aa0a59a22026-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d62026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.56a80e79-9cfe-4361-a90a-9245632efa052026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.770b56aa-fcf3-4327-98d1-d87e5a0372342026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEVERITYRX, LLC42788adf-a54d-3545-e063-6394a90a8c692025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.746dcdfd-7dfb-4a29-e053-2991aa0a8a4c2025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepack100a31f2-9a8e-4245-a09c-05583c3244c32025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepack1c13555e-acfc-4a3a-93cd-e6f012f36c612025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5366a055-47fd-41eb-81d8-ffb3be1dc38c2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.61b56917-1442-4068-86d8-0e5a5a59e6122025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutions329382fb-ccf8-488d-a0b2-68ff959a08462024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEA-S Medication Solutionsaecd05bf-e7ba-4cab-9494-4ce3bbd1aa992024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackbe6c29cd-1692-4dd3-868e-7efcb3a850562024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a9de8b29-5cd2-a49d-e053-2995a90a4f0e2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEDirectRX2823a922-3217-6062-e054-00144ff88e882024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAlembic Pharmaceuticals Limited88a8db46-0fc9-48cd-b7cc-ac9c9cdea1002023-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.b60034a6-b8ba-4e54-9ef0-029965e67bc02020-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091368
application number: ANDA091368

Additional Listing Data#

Finished product
Yes
Brand name base
clonidine hydrochloride
Listing expiration
2027-12-31

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
53df40e7-dd2b-d40e-e063-6394a90a21c4Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
67296-2260-16729622600110 TABLET in 1 BOTTLE (67296-2260-1)10 tablet2016-05-030Current