clonidine

Generic: clonidine

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

Drug Facts

Product Profile

Brand Name clonidine
Generic Name clonidine
Labeler mayne pharma inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

clonidine .3 mg/24h

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-455
Product ID 51862-455_3dfdaa58-ccab-5f9a-e063-6394a90a3cbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079090
Listing Expiration 2026-12-31
Marketing Start 2016-08-03

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 51862455
Hyphenated Format 51862-455

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 (source: ndc)
Generic Name clonidine (source: ndc)
Application Number ANDA079090 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .3 mg/24h
source: ndc
Packaging
  • HOW SUPPLIED Clonidine transdermal system USP 0.1 mg/day, 0.2 mg/day or 0.3 mg/day are available as 4 pouched systems and 4 adhesive covers per carton. Each system is a round corner, rectangular flexible transdermal system with a tan matte backing and clear membrane. *Programmed Delivery - Clonidine in vivo Per Day Over 1 Week Debossed Total Clonidine Content Size NDC (for 4 systems) Clonidine Transdermal System 0.1 mg/day 0.1 mg 453 Clonidine 0.1 mg/day 3.09 mg 4.33 cm 2 NDC 51862-453-04 Clonidine Transdermal System 0.2 mg/day 0.2 mg 454 Clonidine 0.2 mg/day 6.19 mg 8.67 cm 2 NDC 51862-454-04 Clonidine Transdermal System 0.3 mg/day 0.3 mg 455 Clonidine 0.3 mg/day 9.28 mg 13 cm 2 NDC 51862-455-04 STORAGE AND HANDLING Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • PRINCIPAL DISPLAY PANEL - 0.1 mg Patch Pouch Carton NDC 51862-453-04 Clonidine Transdermal System USP 0.1 mg/day Programmed in vivo delivery of 0.1 mg per day for one week. To avoid possible burns, remove the clonidine transdermal system patch before undergoing an MRI (magnetic resonance imaging) procedure. Rx Only 4 Systems and 4 Adhesive Covers mayne pharma PRINCIPAL DISPLAY PANEL - 0.1 mg Patch Pouch Carton
  • PRINCIPAL DISPLAY PANEL - 0.2 mg Patch Pouch Carton NDC 51862-454-04 Clonidine Transdermal System USP 0.2 mg/day Programmed in vivo delivery of 0.2 mg per day for one week. To avoid possible burns, remove the clonidine transdermal system patch before undergoing an MRI (magnetic resonance imaging) procedure. Rx Only 4 Systems and 4 Adhesive Covers mayne pharma PRINCIPAL DISPLAY PANEL - 0.2 mg Patch Pouch Carton
  • PRINCIPAL DISPLAY PANEL - 0.3 mg Patch Pouch Carton NDC 51862-455-04 Clonidine Transdermal System USP 0.3 mg/day Programmed in vivo delivery of 0.3 mg per day for one week. To avoid possible burns, remove the clonidine transdermal system patch before undergoing an MRI (magnetic resonance imaging) procedure. Rx Only 4 Systems and 4 Adhesive Covers mayne pharma PRINCIPAL DISPLAY PANEL - 0.3 mg Patch Pouch Carton
source: label

Packages (0)

No package records.

Ingredients (1)

clonidine (.3 mg/24h)

Linked Drug Pages (1)

Clonidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "3dfdaa58-ccab-5f9a-e063-6394a90a3cbb", "openfda": {"nui": ["N0000009918", "N0000175554"], "unii": ["MN3L5RMN02"], "rxcui": ["998671", "998675", "998679"], "spl_set_id": ["c41eb913-5e47-46c4-9d96-9a67f8380919"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Clonidine", "product_id": "51862-455_3dfdaa58-ccab-5f9a-e063-6394a90a3cbb", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "51862-455", "generic_name": "CLONIDINE", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clonidine", "active_ingredients": [{"name": "CLONIDINE", "strength": ".3 mg/24h"}], "application_number": "ANDA079090", "marketing_category": "ANDA", "marketing_start_date": "20160803", "listing_expiration_date": "20261231"}