Home NDC 0591-3508-54 NDC 0591-3508-54 - Clonidine transdermal system This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 0591-3508
Requested NDC 0591-3508-54
Package NDCs from labels 0591-3508-54, 0591-3508-04
Manufacturer Actavis Pharma, Inc.
Effective date 2023-11-28
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3508-04 Clonidine transdermal system 4 in 1 CARTON PATCH 4 13 0591-3508-54 Clonidine transdermal system 1 in 1 POUCH PATCH 1 13 0591-3508-54 Clonidine transdermal system 7 d in 1 PATCH PATCH 7 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3508 CLONIDINE TRANSDERMAL SYSTEM (CLONIDINE) PATCH [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 3 package rows 20231216_99a59495-2a48-4276-bbe3-cdd55a45aba4.zip
DailyMed Socrata Ingredients# 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 ยท 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clonidine CLONIDINE Mylan Pharmaceuticals Inc. 7adfc439-e6d0-4593-87dd-0eef36d33c6d 2026-06-23 Warnings, Adverse reactions Exact identifier rxcui: 998675 rxcui: 998671 rxcui: 998679 unii: MN3L5RMN02 Nexiclon XR CLONIDINE Rosemont Pharmaceuticals LLC dad35a6f-d57e-f302-e053-2995a90a9efb 2026-04-15 Warnings, Adverse reactions Exact identifier unii: MN3L5RMN02 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 rxcui: 998675 rxcui: 998671 rxcui: 998679 unii: MN3L5RMN02 Catapres-TTS-1 CLONIDINE TRANSDERMAL SYSTEM Technomed Inc. 39e1d35e-533c-4647-8649-8168a6e92dfa 2026-01-06 Warnings, Adverse reactions Exact identifier rxcui: 998675 rxcui: 998671 rxcui: 998679 unii: MN3L5RMN02 Clonidine CLONIDINE Mayne Pharma Inc. c41eb913-5e47-46c4-9d96-9a67f8380919 2025-09-04 Warnings, Adverse reactions Exact identifier rxcui: 998675 rxcui: 998671 rxcui: 998679 unii: MN3L5RMN02 Clonidine CLONIDINE Dr. Reddy's Labratories Inc. a179570b-eef1-176a-820c-5f603d222a60 2024-02-05 Warnings, Adverse reactions Exact identifier rxcui: 998675 rxcui: 998671 rxcui: 998679 unii: MN3L5RMN02 Clonidine CLONIDINE TruPharma, LLC 2311836b-de63-4e8c-a021-600c40110024 2024-01-11 Warnings, Adverse reactions Exact identifier unii: MN3L5RMN02 Clonidine CLONIDINE PALMETTO PHARMACEUTICALS INC. e93324f1-ad83-7bbe-e053-2995a90a8c9e 2024-01-11 Warnings, Adverse reactions Exact identifier unii: MN3L5RMN02 Clonidine transdermal system CLONIDINE Actavis Pharma, Inc. 99a59495-2a48-4276-bbe3-cdd55a45aba4 2023-11-28 Warnings, Adverse reactions Exact identifier application number: ANDA090873 ndc (package): 0591-3508-54 ndc (package): 0591-3510-54 ndc (package): 0591-3508-04 ndc (package): 0591-3509-54 ndc (package): 0591-3509-04 ndc (package): 0591-3510-04 ndc (product): 0591-3508 ndc (product): 0591-3510 ndc (product): 0591-3509 ndc11 (package): 00591350854 rxcui: 998675 rxcui: 998671 rxcui: 998679 spl id: 996f475b-4f8b-4487-b5c1-6e5c4f284045 spl set id: 99a59495-2a48-4276-bbe3-cdd55a45aba4 unii: MN3L5RMN02
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.