Home NDC 62135-728 GUANFACINE HYDROCHLORIDE
Product NDC 62135-728
11-digit product format 621350728
Labeler code 62135
Product ID 62135-728_459cdf6c-19fa-c506-e063-6394a90a7393
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name guanfacine
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA216399
Marketing category ANDA
Marketing start 2022-09-01
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 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 A216399-001 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 A216399-002 GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08
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 · 58 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 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216399-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2022-06-08 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216399-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 2022-06-08 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 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 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 62135-728-90 GUANFACINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-728 GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20241030_fa7ae501-ee34-4e50-9052-7952e36bbd0e.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 · 2 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 62135-728-90 62135072890 90 TABLET in 1 BOTTLE (62135-728-90) 90 tablet 2023-07-12 No No Current