NDC 67857-700

SECTRAL

Acebutolol Hydrochloride

SECTRAL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Promius Pharma, Llc. The primary component is Acebutolol Hydrochloride.

Product ID67857-700_8d674ec6-61e4-41f2-91f8-4a0df9c141b9
NDC67857-700
Product TypeHuman Prescription Drug
Proprietary NameSECTRAL
Generic NameAcebutolol Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1984-12-28
Marketing CategoryNDA / NDA
Application NumberNDA018917
Labeler NamePromius Pharma, LLC
Substance NameACEBUTOLOL HYDROCHLORIDE
Active Ingredient Strength200 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 67857-700-01

100 CAPSULE in 1 BOTTLE, PLASTIC (67857-700-01)
Marketing Start Date1984-12-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67857-700-01 [67857070001]

SECTRAL CAPSULE
Marketing CategoryNDA
Application NumberNDA018917
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1984-12-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACEBUTOLOL HYDROCHLORIDE200 mg/1

OpenFDA Data

SPL SET ID:7eee95bf-0452-4d6e-9712-33403768695a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 998691
  • 998689
  • 998687
  • 998685

    • Pharmacological Class

    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "SECTRAL" or generic name "Acebutolol Hydrochloride"

    NDCBrand NameGeneric Name
    67857-700SECTRALacebutolol hydrochloride
    67857-701SECTRALacebutolol hydrochloride
    0378-1200Acebutolol Hydrochlorideacebutolol hydrochloride
    0378-1400Acebutolol Hydrochlorideacebutolol hydrochloride
    10135-630Acebutolol HydrochlorideAcebutolol Hydrochloride
    10135-631Acebutolol HydrochlorideAcebutolol Hydrochloride
    42291-101Acebutolol HydrochlorideAcebutolol Hydrochloride
    42291-102Acebutolol HydrochlorideAcebutolol Hydrochloride
    50268-050Acebutolol HydrochlorideAcebutolol Hydrochloride
    51407-666Acebutolol HydrochlorideAcebutolol Hydrochloride
    51407-667Acebutolol HydrochlorideAcebutolol Hydrochloride
    53746-669Acebutolol HydrochlorideAcebutolol Hydrochloride
    53746-670Acebutolol HydrochlorideAcebutolol Hydrochloride
    62559-255Acebutolol HydrochlorideAcebutolol Hydrochloride
    62559-256Acebutolol HydrochlorideAcebutolol Hydrochloride
    65162-669Acebutolol HydrochlorideAcebutolol Hydrochloride
    65162-670Acebutolol HydrochlorideAcebutolol Hydrochloride

    Trademark Results [SECTRAL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SECTRAL
    SECTRAL
    90518010 not registered Live/Pending
    Woodward Pharma Services LLC
    2021-02-08
    SECTRAL
    SECTRAL
    73074265 1061086 Live/Registered
    RHONE-POULENC INDUSTRIES, SOCIETE ANONYME
    1976-01-14
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.