clonidine transdermal system

Generic: clonidine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clonidine transdermal system
Generic Name clonidine
Labeler actavis pharma, inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

clonidine .1 mg/d

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3508
Product ID 0591-3508_996f475b-4f8b-4487-b5c1-6e5c4f284045
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090873
Listing Expiration 2026-12-31
Marketing Start 2014-05-06

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913508
Hyphenated Format 0591-3508

Supplemental Identifiers

RxCUI
998671 998675 998679
UNII
MN3L5RMN02
NUI
N0000009918 N0000175554

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clonidine transdermal system (source: ndc)
Generic Name clonidine (source: ndc)
Application Number ANDA090873 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .1 mg/d
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (0591-3508-04) / 1 PATCH in 1 POUCH (0591-3508-54) / 7 d in 1 PATCH
source: ndc

Packages (1)

0591-3508-04 4 POUCH in 1 CARTON (0591-3508-04) / 1 PATCH in 1 POUCH (0591-3508-54) / 7 d in 1 PATCH

Ingredients (1)

clonidine (.1 mg/d)

Linked Drug Pages (1)

Clonidine transdermal system ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "996f475b-4f8b-4487-b5c1-6e5c4f284045", "openfda": {"nui": ["N0000009918", "N0000175554"], "unii": ["MN3L5RMN02"], "rxcui": ["998671", "998675", "998679"], "spl_set_id": ["99a59495-2a48-4276-bbe3-cdd55a45aba4"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (0591-3508-04)  / 1 PATCH in 1 POUCH (0591-3508-54)  / 7 d in 1 PATCH", "package_ndc": "0591-3508-04", "marketing_start_date": "20140506"}], "brand_name": "Clonidine transdermal system", "product_id": "0591-3508_996f475b-4f8b-4487-b5c1-6e5c4f284045", "dosage_form": "PATCH", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "0591-3508", "generic_name": "Clonidine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonidine transdermal system", "active_ingredients": [{"name": "CLONIDINE", "strength": ".1 mg/d"}], "application_number": "ANDA090873", "marketing_category": "ANDA", "marketing_start_date": "20140506", "listing_expiration_date": "20261231"}