Home NDC 52817-507 Clonidine Transdermal System USP, 0.3 mg/day
Product NDC 52817-507
11-digit product format 528170507
Labeler code 52817
Product ID 52817-507_cb042bcb-7841-43e9-bf1a-0ab908860766
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clonidine transdermal system
Dosage form PATCH
Route TRANSDERMAL
Labeler TruPharma, LLC
Application NDA018891
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2026-03-30
Substance CLONIDINE
Active strength .3 mg/d
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 42 .
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 N018891-001 CATAPRES-TTS-1 CLONIDINE 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 N018891-002 CATAPRES-TTS-2 CLONIDINE 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 N018891-003 CATAPRES-TTS-3 CLONIDINE 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10
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 · 126 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 2026-08-18 06:07:40 2026-07 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-002 CATAPRES-TTS-2 0.2MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018891-003 CATAPRES-TTS-3 0.3MG/24HR SYSTEM / TRANSDERMAL AB RLD, RS 1984-10-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018891-001 CATAPRES-TTS-1 0.1MG/24HR SYSTEM / TRANSDERMAL AB RLD 1984-10-10 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clonidine Transdermal System USP, 0.3 mg/day
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLONIDINE .3 mg/d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MN3L5RMN02 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998671 Internal RxNorm lookup 998675 Internal RxNorm lookup 998679 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 52817-507-04 Clonidine Transdermal System USP, 0.3 mg/day 1 in 1 POUCH PATCH 1 1 52817-507-04 Clonidine Transdermal System USP, 0.3 mg/day 4 in 1 CARTON PATCH 4 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clonidine Transdermal System USP, 0.1 mg/day CLONIDINE TRANSDERMAL SYSTEM TruPharma, LLC 0fcfcdb5-0662-41d9-919b-c66d4f4f0c8b 2026-03-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 ndc (product): 52817-507 Catapres-TTS-1 CLONIDINE TRANSDERMAL SYSTEM Technomed Inc. 39e1d35e-533c-4647-8649-8168a6e92dfa 2026-01-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 Clonidine Transdermal System USP, 0.1 mg/day CLONIDINE TRANSDERMAL SYSTEM TruPharma, LLC 05d520bf-3ab7-4337-9f38-4418e5e7e1e9 2025-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891 Catapres-TTS-1 CLONIDINE TRANSDERMAL SYSTEM Technomed Inc. d4a55825-7041-42f4-b3b2-dd7a25dbe793 2024-10-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 018891 application number: NDA018891
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52817-507-04 52817050704 4 POUCH in 1 CARTON (52817-507-04) / 1 PATCH in 1 POUCH / 1 d in 1 PATCH 4 pouch 2026-03-30 No No Current