Home NDC 60429-861 Guanfacine
Product NDC 60429-861
11-digit product format 604290861
Labeler code 60429
Product ID 60429-861_7c73fc75-af9e-177c-e053-2a91aa0ada56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name guanfacine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA074796
Marketing category ANDA
Marketing start 2017-03-07
Marketing end 0000-00-00
Substance GUANFACINE HYDROCHLORIDE
Active strength 1 mg/1
Pharmacologic classes Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A074796-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 A074796-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27
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 · 84 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 2026-08-18 06:07:40 2026-07 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 1997-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 1997-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 1997-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 1997-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 1997-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 1997-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RS 1997-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB RS 1997-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074796-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 1997-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074796-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL 1997-01-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-861-01 60429086101 100 TABLET in 1 BOTTLE (60429-861-01) 100 tablet 2017-03-07 0000-00-00 No No Current 60429-861-90 60429086190 90 TABLET in 1 BOTTLE (60429-861-90) 90 tablet 2017-03-07 0000-00-00 No No Current