Home NDC 70518-4564 Guanfacine
Product NDC 70518-4564
11-digit product format 705184564
Labeler code 70518
Product ID 70518-4564_49ee625b-ae00-dde3-e063-6294a90a87e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gaunfacine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA216828
Marketing category ANDA
Marketing start 2026-02-03
Substance GUANFACINE HYDROCHLORIDE
Active strength 2 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216828-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 A216828-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-08-01 22:54:32 2026-06 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 a50c72e98297…2026-08-01 22:54:32 2026-06 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A216828-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A216828-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Guanfacine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUANFACINE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PML56A160O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197746 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 70518-4564-0 Guanfacine 30 in 1 BLISTER PACK TABLET 30 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4564-0 70518456400 30 TABLET in 1 BLISTER PACK (70518-4564-0) 30 tablet 2026-02-03 No No Current