Home NDC 0591-0444-00 Guanfacine
Product NDC 0591-0444
Requested package NDC 0591-0444-00
11-digit product format 005910444
Labeler code 0591
Product ID 0591-0444_3ed0b0fa-4fd2-494b-ba55-52fcf77bc9d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Guanfacine
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA074145
Marketing category ANDA
Marketing start 1995-10-17
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 2026-12-31
Current FDA listing Yes 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 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 · 82 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 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…2021-12-28 21:50 UTC 2021-12 A074145-001 GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 1995-10-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074145-002 GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET / ORAL AB 1995-10-17 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 1 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 0591-0444-01 Guanfacine 100 in 1 BOTTLE, PLASTIC TABLET 100 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUANFACINE HYDROCHLORIDE ACTIVE INGREDIENT PML56A160O GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 GUANFACINE ACTIVE MOIETY 30OMY4G3MK GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 12 GUANFACINE HYDROCHLORIDE ACTIVE INGREDIENT PML56A160O GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 GUANFACINE ACTIVE MOIETY 30OMY4G3MK GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUANFACINE TABLET [PHYSICIANS TOTAL CARE, INC.] 3 GUANFACINE HYDROCHLORIDE ACTIVE INGREDIENT PML56A160O GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 GUANFACINE ACTIVE MOIETY 30OMY4G3MK GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP GUANFACINE TABLET [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-0444 GUANFACINE TABLET [ACTAVIS PHARMA, INC.] 19 Current NDC, Legacy NDC, 1 package rows 20250130_a81b956b-f004-4426-ba20-375ccf21eb71.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 Status 0591-0444-00 00591044400 77000 TABLET in 1 BAG (0591-0444-00) 77000 tablet 17-OCT-95 Current