FDA.reportPublic FDA data

Acebutolol Hydrochloride

Product NDC
65162-670
11-digit product format
651620670
Labeler code
65162
Product ID
65162-670_6e350ff3-ef29-4f7b-acc2-5f4bfe188233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acebutolol Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA075047
Marketing category
ANDA
Marketing start
2009-12-01
Substance
ACEBUTOLOL HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acebutolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACEBUTOLOL HYDROCHLORIDE400 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
65162-670-03Acebutolol Hydrochloride30 in 1 BOTTLECAPSULE3014
65162-670-10Acebutolol Hydrochloride100 in 1 BOTTLECAPSULE10014
65162-670-50Acebutolol Hydrochloride500 in 1 BOTTLECAPSULE50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-670-10EA - Each65162-670a1b5aecb-1280-45bf-a747-f2146f8a6d4612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACEBUTOLOL HYDROCHLORIDEACTIVE INGREDIENTB025Y34C54ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
ACEBUTOLOLACTIVE MOIETY67P356D8GHACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]6
ACEBUTOLOL HYDROCHLORIDEACTIVE INGREDIENTB025Y34C54ACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
ACEBUTOLOLACTIVE MOIETY67P356D8GHACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACEBUTOLOL HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-670ACEBUTOLOL HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 3 package rows20241025_28f8c26c-a1e1-4485-a45f-05c82f7a34b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998689acebutolol HCl 200 MG Oral CapsulePSN28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998685acebutolol HCl 400 MG Oral CapsulePSN28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998689acebutolol 200 MG Oral CapsuleSCD28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998685acebutolol 400 MG Oral CapsuleSCD28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSY28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998685acebutolol (as acebutolol HCl) 400 MG Oral CapsuleSY28f8c26c-a1e1-4485-a45f-05c82f7a34b514
998689acebutolol HCl 200 MG Oral CapsulePSN201b752c-64b4-4687-acc1-3a92bfda864e3
998685acebutolol HCl 400 MG Oral CapsulePSN201b752c-64b4-4687-acc1-3a92bfda864e3
998689acebutolol 200 MG Oral CapsuleSCD201b752c-64b4-4687-acc1-3a92bfda864e3
998685acebutolol 400 MG Oral CapsuleSCD201b752c-64b4-4687-acc1-3a92bfda864e3
998689acebutolol (as acebutolol HCl) 200 MG Oral CapsuleSY201b752c-64b4-4687-acc1-3a92bfda864e3
998685acebutolol (as acebutolol HCl) 400 MG Oral CapsuleSY201b752c-64b4-4687-acc1-3a92bfda864e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-670-036516206700330 CAPSULE in 1 BOTTLE (65162-670-03) 30 capsule2009-12-010000-00-00NoNoCurrent
65162-670-1065162067010100 CAPSULE in 1 BOTTLE (65162-670-10) 100 capsule2009-12-010000-00-00NoNoCurrent
65162-670-5065162067050500 CAPSULE in 1 BOTTLE (65162-670-50) 500 capsule2009-12-010000-00-00NoNoCurrent