Home NDC 70518-1369 Guanfacine
Product NDC 70518-1369
11-digit product format 705181369
Labeler code 70518
Product ID 70518-1369_e3dc02c1-6a89-6e0c-e053-2995a90afd01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Guanfacine
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA074145
Marketing category ANDA
Marketing start 2018-08-10
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A074145-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 A074145-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17
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 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-1369 GUANFACINE TABLET [REMEDYREPACK INC.] 10 Legacy NDC 20250511_b6b1d427-e19a-4fc1-b518-f58bacc46736.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 · 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 70518-1369-0 70518136900 30 TABLET in 1 BLISTER PACK (70518-1369-0) 30 tablet 2018-08-10 0000-00-00 No No Current