NDC 61919-410

KEFLEX

Cephalexin

KEFLEX is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Cephalexin.

Product ID61919-410_37ad16fe-df8f-0f36-e054-00144ff88e88
NDC61919-410
Product TypeHuman Prescription Drug
Proprietary NameKEFLEX
Generic NameCephalexin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-07-14
Marketing CategoryANDA / ANDA
Application NumberANDA065248
Labeler NameDIRECT RX
Substance NameCEPHALEXIN
Active Ingredient Strength500 mg/1
Pharm ClassesCephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-410-30

30 CAPSULE in 1 BOTTLE (61919-410-30)
Marketing Start Date2016-07-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-410-30 [61919041030]

KEFLEX CAPSULE
Marketing CategoryANDA
Application NumberANDA065248
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-14

Drug Details

Active Ingredients

IngredientStrength
CEPHALEXIN500 mg/1

OpenFDA Data

SPL SET ID:37ad16fe-df8e-0f36-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 212339
  • 309114
  • Pharmacological Class

    • Cephalosporin Antibacterial [EPC]
    • Cephalosporins [CS]

    NDC Crossover Matching brand name "KEFLEX" or generic name "Cephalexin"

    NDCBrand NameGeneric Name
    58463-011KEFLEXKEFLEX
    58463-012KEFLEXKEFLEX
    58463-013KEFLEXKEFLEX
    59630-112KeflexKeflex
    59630-113KeflexKeflex
    59630-115KeflexKeflex
    61919-410KEFLEXKEFLEX
    80425-0006KeflexKeflex
    80425-0121KeflexKeflex
    80425-0005KeflexKeflex
    0093-2238CephalexinCephalexin
    0093-2240CephalexinCephalexin
    0093-3145CephalexinCephalexin
    0093-3147CephalexinCephalexin
    0093-4175CephalexinCephalexin
    0093-4177CephalexinCephalexin
    0143-9769CephalexinCephalexin
    0143-9770CephalexinCephalexin
    0143-9897CephalexinCephalexin
    0143-9898CephalexinCephalexin

    Trademark Results [KEFLEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KEFLEX
    KEFLEX
    76676940 not registered Dead/Abandoned
    KEFLEX, INC.
    2007-05-16
    KEFLEX
    KEFLEX
    72311361 0881598 Live/Registered
    ELI LILLY AND COMPANY
    1968-11-05
    KEFLEX
    KEFLEX
    71678168 0613391 Dead/Expired
    U. S. FLEXIBLE METALLIC TUBING CO.
    1954-12-10

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.