Home NDC 42806-296 Guanfacine
Product NDC 42806-296
11-digit product format 428060296
Labeler code 42806
Product ID 42806-296_d0ca35de-12e8-4154-825a-c82eed36efd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Guanfacine
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA074673
Marketing category ANDA
Marketing start 2013-12-02
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 2026-12-31
Current FDA listing Yes 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 A074673-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 A074673-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28
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 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074673-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1997-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074673-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1997-02-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Guanfacine
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197745 Internal RxNorm lookup 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 42806-296-01 Guanfacine 100 in 1 BOTTLE TABLET 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUANFACINE HYDROCHLORIDE ACTIVE INGREDIENT PML56A160O GUANFACINE TABLET [EPIC PHARMA, LLC] 3 GUANFACINE ACTIVE MOIETY 30OMY4G3MK GUANFACINE TABLET [EPIC PHARMA, LLC] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GUANFACINE TABLET [EPIC PHARMA, LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUANFACINE TABLET [EPIC PHARMA, LLC] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GUANFACINE TABLET [EPIC PHARMA, LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GUANFACINE TABLET [EPIC PHARMA, LLC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GUANFACINE TABLET [EPIC PHARMA, LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U GUANFACINE TABLET [EPIC PHARMA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-296 GUANFACINE TABLET [EPIC PHARMA, LLC] 12 Current NDC, Legacy NDC, 1 package rows 20231221_fac4a4c2-f5f0-46ef-b76b-315abe9136fa.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42806-296-01 42806029601 100 TABLET in 1 BOTTLE (42806-296-01) 100 tablet 2019-05-30 0000-00-00 No No Current