FDA.reportPublic FDA data

Acebutolol Hydrochloride

Product NDC
50268-050
11-digit product format
502680050
Labeler code
50268
Product ID
50268-050_3f158c97-90b4-1c5e-e063-6294a90a6a65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acebutolol Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA075047
Marketing category
ANDA
Marketing start
2010-09-16
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
Rxcui998689

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
50268-050-11Acebutolol Hydrochloride1 in 1 BLISTER PACKCAPSULE118
50268-050-15Acebutolol Hydrochloride50 in 1 BOXCAPSULE5018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-050-11EA - Each50268-050debf66d6-346c-4d32-afca-850f648fccd812015-04-03
50268-050-15EA - Each50268-05048be9b7f-4a04-4f49-b2b7-9225621fedcd12012-07-24

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
50268-050ACEBUTOLOL HYDROCHLORIDE CAPSULE [AVPAK]17Current NDC, Legacy NDC, 2 package rows20240110_ff68a002-d46d-4f9f-0705-427844ea3655.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-050-11502680050111 in 1 BLISTER PACKHistorical
50268-050-155026800501550 BLISTER PACK in 1 BOX (50268-050-15) / 1 CAPSULE in 1 BLISTER PACK (50268-050-11) 50 blister pack2010-09-160000-00-00NoNoCurrent