FDA.reportPublic FDA data

Guanfacine

Product NDC
73141-018
11-digit product format
731410018
Labeler code
73141
Product ID
73141-018_32c1e44a-6ccf-c3c7-e063-6394a90ad7fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gaunfacine
Dosage form
TABLET
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals
Application
ANDA216828
Marketing category
ANDA
Marketing start
2025-04-08
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216828-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2023-10-05
A216828-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2023-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A216828-001AB
A216828-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216828-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2023-10-05a50c72e98297…
2026-08-01 22:54:322026-06A216828-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2023-10-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216828-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A216828-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGAUNFACINEREMEDYREPACK INC.46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e02026-02-03Adverse reactionsExact identifier
application applno (ANDA): 216828
application number: ANDA216828
GuanfacineGAUNFACINEA2A Integrated Pharmaceuticals00c3b4d2-fc4d-4e68-9157-eb29d927deaf2025-02-28Adverse reactionsExact identifier
application applno (ANDA): 216828
application number: ANDA216828
ndc (product): 73141-018
GuanfacineGAUNFACINEi3 Pharmaceuticals, LLC387b33dd-829d-4dab-afe4-078fd15590272024-11-05Adverse reactionsExact identifier
application applno (ANDA): 216828
application number: ANDA216828

Additional Listing Data#

Finished product
Yes
Brand name base
Guanfacine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PML56A160OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197745Internal RxNorm lookup
197746Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
00c3b4d2-fc4d-4e68-9157-eb29d927deafAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73141-018-04Guanfacine100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73141-018-04EA - Each73141-0188b5e8b8f-940f-4ae0-82fc-b7849406475a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-018GUANFACINE (GAUNFACINE) TABLET [A2A INTEGRATED PHARMACEUTICALS]1Current NDC, 1 package rows20250416_00c3b4d2-fc4d-4e68-9157-eb29d927deaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197745guanFACINE HCl 1 MG Oral TabletPSN00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanFACINE HCl 2 MG Oral TabletPSN00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197745guanfacine 1 MG Oral TabletSCD00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanfacine 2 MG Oral TabletSCD00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197745guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral TabletSY00c3b4d2-fc4d-4e68-9157-eb29d927deaf1
197746guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral TabletSY00c3b4d2-fc4d-4e68-9157-eb29d927deaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73141-018-0473141001804100 TABLET in 1 BOTTLE (73141-018-04) 100 tablet2025-04-08NoNoCurrent