Home NDC 68094-065 Guanfacine Hydrochloride
Product NDC 68094-065
11-digit product format 680940065
Labeler code 68094
Product ID 68094-065_370c543f-fc34-4fff-804c-3b990de04588
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Guanfacine
Dosage form TABLET
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA075109
Marketing category ANDA
Marketing start 2023-01-31
Substance GUANFACINE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A075109-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 A075109-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1998-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075109-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1998-11-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075109-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1998-11-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Guanfacine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUANFACINE HYDROCHLORIDE 1 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 197745 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 68094-065-59 Guanfacine Hydrochloride 10 in 1 BLISTER PACK TABLET 10 2 68094-065-62 Guanfacine Hydrochloride 3 in 1 CARTON TABLET 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-065 GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [PRECISION DOSE, INC.] 1 Current NDC, 2 package rows 20230131_a80dfdc4-b9a7-4f8e-af67-dea30bc063ac.zip
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 · 5 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 68094-065-59 68094006559 10 in 1 BLISTER PACK Historical 68094-065-62 68094006562 3 BLISTER PACK in 1 CARTON (68094-065-62) / 10 TABLET in 1 BLISTER PACK (68094-065-59) 3 blister pack 2023-01-31 No No Current