FDA.reportPublic FDA data

GUANFACINE

Product NDC
62332-747
11-digit product format
623320747
Labeler code
62332
Product ID
62332-747_e4b78c34-efde-4552-ae2a-c3ce006bb477
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GUANFACINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217269
Marketing category
ANDA
Marketing start
2023-08-08
Substance
GUANFACINE HYDROCHLORIDE
Active strength
3 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPML56A160O
Rxcui862006, 862013, 862019, 862025

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-747-31GUANFACINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
62332-747-91GUANFACINE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-747-31EA - Each62332-74724a0734b-b786-4dd5-8c54-93cb9590ddf212023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-747GUANFACINE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, 2 package rows20250524_9db7def2-c6f9-4d7d-a403-fc615358913a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN9db7def2-c6f9-4d7d-a403-fc615358913a4
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN9db7def2-c6f9-4d7d-a403-fc615358913a4
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN9db7def2-c6f9-4d7d-a403-fc615358913a4
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN9db7def2-c6f9-4d7d-a403-fc615358913a4
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD9db7def2-c6f9-4d7d-a403-fc615358913a4
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD9db7def2-c6f9-4d7d-a403-fc615358913a4
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD9db7def2-c6f9-4d7d-a403-fc615358913a4
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD9db7def2-c6f9-4d7d-a403-fc615358913a4
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY9db7def2-c6f9-4d7d-a403-fc615358913a4
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN0836a1d5-f1fc-4b94-9667-667278a74c931
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD0836a1d5-f1fc-4b94-9667-667278a74c931
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY0836a1d5-f1fc-4b94-9667-667278a74c931
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY0836a1d5-f1fc-4b94-9667-667278a74c931
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-747-3162332074731100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-747-31) 2023-08-08NoNoHistorical
62332-747-91623320747911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-747-91) 2023-08-08NoNoHistorical