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 43 .
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.
Product history page 1 of 2 · 44 observed 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 2026-09-14 22:38:34 2026-08 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216828-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-05 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216828-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-05 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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 · 3 matching rows.
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