Guanfacine

Product NDC
70518-2771
11-digit product format
705182771
Labeler code
70518
Product ID
70518-2771_4a8f6fe7-ff80-5bff-e063-6294a90a39ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201408
Marketing category
ANDA
Marketing start
2020-06-08
Substance
GUANFACINE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201408-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02
A201408-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02
A201408-003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02
A201408-004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A201408-001AB
A201408-002AB
A201408-003AB
A201408-004AB

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 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2015-06-02d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201408-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201408-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201408-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201408-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201408-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201408-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201408-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201408-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201408-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201408-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201408-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201408-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201408-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Brand name suffix
Extended-Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30OMY4G3MKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
862006Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36fd53a6-7006-4955-a3cd-b1c08cf84d6cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2771-0GuanfacineExtended-Release30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3013
70518-2771-1GuanfacineExtended-Release100 in 1 BOXTABLET, EXTENDED RELEASE10013
70518-2771-2GuanfacineExtended-Release1 in 1 POUCHTABLET, EXTENDED RELEASE113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2771GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250510_36fd53a6-7006-4955-a3cd-b1c08cf84d6c.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guanfacine Extended-ReleaseGUANFACINEREMEDYREPACK INC.3ec4fed6-cafc-49a0-9540-8d70ac4357692026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201408
application number: ANDA201408
Guanfacine Extended-ReleaseGUANFACINEGolden State Medical Supply, Inc.6006df06-0448-462d-b81e-7add50a6d71b2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201408
application number: ANDA201408
Guanfacine Extended-ReleaseGUANFACINEREMEDYREPACK INC.36fd53a6-7006-4955-a3cd-b1c08cf84d6c2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201408
application number: ANDA201408
ndc (product): 70518-2771
Guanfacine Extended-ReleaseGUANFACINEUpsher-Smith Laboratories, LLC07a701e2-39b7-4bb1-a7c7-d9baed4ab18a2025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201408
application number: ANDA201408
Guanfacine Extended-ReleaseGUANFACINEProficient Rx LP6460ad33-4feb-4a4d-9958-5010840463892022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201408
application number: ANDA201408

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY36fd53a6-7006-4955-a3cd-b1c08cf84d6c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2771-07051827710030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2771-0) 2020-06-080000-00-00NoNoCurrent
70518-2771-170518277101100 POUCH in 1 BOX (70518-2771-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2771-2) 100 pouch2025-01-27NoNoCurrent
70518-2771-2705182771021 in 1 POUCHHistorical