FDA.reportPublic FDA data

Acebutolol Hydrochloride

Product NDC
53746-669
11-digit product format
537460669
Labeler code
53746
Product ID
53746-669_32106d1d-d15a-41e6-9e2a-57394e8ae558
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acebutolol Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA075047
Marketing category
ANDA
Marketing start
2009-12-01
Substance
ACEBUTOLOL HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACEBUTOLOL HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB025Y34C54
Rxcui998685, 998689

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b2b9ebc1-3e2b-b877-2cfb-b7c92cf3c5faProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53746-669-01Acebutolol Hydrochloride100 in 1 BOTTLECAPSULE1007
53746-669-05Acebutolol Hydrochloride500 in 1 BOTTLECAPSULE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-669-01EA - Each53746-66903d4ece2-2409-418e-b357-f7cf55be492d12018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACEBUTOLOL HYDROCHLORIDEACTIVE INGREDIENTB025Y34C54ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
ACEBUTOLOLACTIVE MOIETY67P356D8GHACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
D&c Red No. 28INACTIVE INGREDIENT767IP0Y5NHACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
Fd&c Blue No. 1INACTIVE INGREDIENTH3R47K3TBDACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOAACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
GelatinINACTIVE INGREDIENT2G86QN327LACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
PovidoneINACTIVE INGREDIENTFZ989GH94EACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
Starch, CornINACTIVE INGREDIENTO8232NY3SJACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-669ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]7Current NDC, Legacy NDC, 2 package rows20250107_fe2cd5c0-ee16-4bcb-ad92-3755881dbe79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998689acebutolol HCl 200 MG Oral CapsulePSNff68a002-d46d-4f9f-0705-427844ea365518
998689acebutolol 200 MG Oral CapsuleSCDff68a002-d46d-4f9f-0705-427844ea365518
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSYff68a002-d46d-4f9f-0705-427844ea365518
998689acebutolol HCl 200 MG Oral CapsulePSNfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998685acebutolol HCl 400 MG Oral CapsulePSNfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998689acebutolol 200 MG Oral CapsuleSCDfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998685acebutolol 400 MG Oral CapsuleSCDfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSYfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998685acebutolol (as acebutolol HCl) 400 MG Oral CapsuleSYfe2cd5c0-ee16-4bcb-ad92-3755881dbe797
998689acebutolol HCl 200 MG Oral CapsulePSNfa40a564-a579-15c1-e053-6294a90ad8e92
998689acebutolol 200 MG Oral CapsuleSCDfa40a564-a579-15c1-e053-6294a90ad8e92
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSYfa40a564-a579-15c1-e053-6294a90ad8e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-669-0153746066901100 CAPSULE in 1 BOTTLE (53746-669-01) 100 capsule2009-12-010000-00-00NoNoCurrent
53746-669-0553746066905500 CAPSULE in 1 BOTTLE (53746-669-05) 500 capsule2009-12-010000-00-00NoNoCurrent