guanfacine extended-release

Generic: guanfacine

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

Drug Facts

Product Profile

Brand Name guanfacine extended-release
Generic Name guanfacine
Labeler remedyrepack inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

guanfacine 1 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-2771
Product ID 70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201408
Listing Expiration 2027-12-31
Marketing Start 2020-06-08

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 705182771
Hyphenated Format 70518-2771

Supplemental Identifiers

RxCUI
862006
UNII
30OMY4G3MK
NUI
N0000009918 N0000175554

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 guanfacine extended-release (source: ndc)
Generic Name guanfacine (source: ndc)
Application Number ANDA201408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0)
  • 100 POUCH in 1 BOX (70518-2771-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2)
source: ndc

Packages (2)

70518-2771-0 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0) 70518-2771-1 100 POUCH in 1 BOX (70518-2771-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2)

Ingredients (1)

guanfacine (1 mg/1)

Linked Drug Pages (1)

Guanfacine Extended-Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a8f6fe7-ff80-5bff-e063-6294a90a39ad", "openfda": {"nui": ["N0000009918", "N0000175554"], "unii": ["30OMY4G3MK"], "rxcui": ["862006"], "spl_set_id": ["36fd53a6-7006-4955-a3cd-b1c08cf84d6c"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0)", "package_ndc": "70518-2771-0", "marketing_start_date": "20200608"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-2771-1)  / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2)", "package_ndc": "70518-2771-1", "marketing_start_date": "20250127"}], "brand_name": "Guanfacine Extended-Release", "product_id": "70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]"], "product_ndc": "70518-2771", "generic_name": "Guanfacine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Guanfacine", "brand_name_suffix": "Extended-Release", "active_ingredients": [{"name": "GUANFACINE", "strength": "1 mg/1"}], "application_number": "ANDA201408", "marketing_category": "ANDA", "marketing_start_date": "20200608", "listing_expiration_date": "20271231"}