Home NDC 72888-124-05 Guanfacine
Product NDC 72888-124
Requested package NDC 72888-124-05
11-digit product format 728880124
Labeler code 72888
Product ID 72888-124_473ce2a5-25a3-811b-e063-6294a90a0456
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Guanfacine
Dosage form TABLET
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA216762
Marketing category ANDA
Marketing start 2021-10-01
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 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 A216762-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 A216762-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17
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 2 · 42 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 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL BX 2023-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL BX 2023-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL BX 2023-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL BX 2023-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL BX 2023-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL BX 2023-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216762-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2023-10-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216762-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2023-10-17 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 72888-124-00 Guanfacine 1000 in 1 BOTTLE TABLET 1000 7 72888-124-01 Guanfacine 100 in 1 BOTTLE TABLET 100 7 72888-124-05 Guanfacine 500 in 1 BOTTLE TABLET 500 7 72888-124-30 Guanfacine 30 in 1 BOTTLE TABLET 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-124 GUANFACINE TABLET [ADVAGEN PHARMA LTD] 1 Current NDC, 4 package rows 20231024_87e1ad56-a7b9-431d-a5d2-d52fb64735c7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72888-124-05 72888012405 500 TABLET in 1 BOTTLE (72888-124-05) 500 tablet 2021-10-01 No No Current