Home NDC 60760-992 clonidine hydrochloride
Product NDC 60760-992
11-digit product format 607600992
Labeler code 60760
Product ID 60760-992_55287a5b-73b3-83f2-e063-6394a90a292d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine hydrochloride
Dosage form TABLET
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA078895
Marketing category ANDA
Marketing start 2025-04-15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078895-001 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 A078895-002 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 A078895-003 CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078895-002 CLONIDINE HYDROCHLORIDE 0.2MG TABLET / ORAL AB 2009-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078895-003 CLONIDINE HYDROCHLORIDE 0.3MG TABLET / ORAL AB RS 2009-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078895-001 CLONIDINE HYDROCHLORIDE 0.1MG TABLET / ORAL AB 2009-08-26 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base clonidine hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE HYDROCHLORIDE .1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W76I6XXF06 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 884173 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60760-992-30 clonidine hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET 30 2 60760-992-90 clonidine hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60760-992 CLONIDINE HYDROCHLORIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY] 1 Current NDC, 2 package rows 20250424_32d72d7b-5881-f431-e063-6394a90a3547.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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60760-992-30 60760099230 30 TABLET in 1 BOTTLE, PLASTIC (60760-992-30) 30 tablet 2025-04-15 No No Current 60760-992-90 60760099290 90 TABLET in 1 BOTTLE, PLASTIC (60760-992-90) 90 tablet 2026-04-10 No No Current