NDC 61919-626

NABUMETONE

Nabumetone

NABUMETONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Nabumetone.

Product ID61919-626_8386d434-d9fa-4629-e053-2991aa0aa2f5
NDC61919-626
Product TypeHuman Prescription Drug
Proprietary NameNABUMETONE
Generic NameNabumetone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-03-07
Marketing CategoryANDA / ANDA
Application NumberANDA091083
Labeler NameDIRECT RX
Substance NameNABUMETONE
Active Ingredient Strength500 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61919-626-60

60 TABLET, FILM COATED in 1 BOTTLE (61919-626-60)
Marketing Start Date2019-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-626-60 [61919062660]

NABUMETONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091083
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-07

Drug Details

Active Ingredients

IngredientStrength
NABUMETONE500 mg/1

OpenFDA Data

SPL SET ID:2d8f206e-0853-43ca-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311892
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]

    NDC Crossover Matching brand name "NABUMETONE" or generic name "Nabumetone"

    NDCBrand NameGeneric Name
    0115-1657NabumetoneNabumetone
    0115-1658NabumetoneNabumetone
    0185-0145NabumetoneNabumentone
    0185-0146NabumetoneNabumentone
    0440-5843NabumetoneNabumetone
    0440-5844NabumetoneNabumetone
    0591-3670NabumetoneNabumetone
    0591-3671NabumetoneNabumetone
    0615-7630Nabumetonenabumetone
    0615-7645Nabumetonenabumetone
    0615-7666NabumetoneNabumetone
    0615-7667NabumetoneNabumetone
    10544-003NabumetoneNabumetone
    10544-120NabumetoneNabumetone
    10544-271NabumetoneNabumetone
    10544-273NabumetoneNabumetone
    21695-230NabumetoneNabumetone
    21695-231NabumetoneNabumetone
    33261-077NabumetoneNabumetone
    33261-078NabumetoneNabumetone
    33358-251NabumetoneNabumetone
    33358-252NabumetoneNabumetone
    35356-685NabumetoneNabumentone
    35356-686NabumetoneNabumetone
    35356-687NabumetoneNabumetone
    35356-726NabumetoneNabumetone
    68084-051NabumetoneNabumetone
    68151-0574NabumetoneNabumetone
    68180-142NabumetoneNabumetone
    68180-141NabumetoneNabumetone
    68462-359NabumetoneNabumetone
    68462-358NabumetoneNabumetone
    68788-7220NabumetoneNabumetone
    68788-9909NabumetoneNabumetone
    68788-9908NabumetoneNabumetone
    69097-965NabumetoneNabumetone
    69097-966NabumetoneNabumetone
    70518-0934NabumetoneNabumetone
    70518-0614NabumetoneNabumetone
    70518-0698NabumetoneNabumetone
    70934-013NabumetoneNabumetone
    71205-030NabumetoneNabumetone
    71335-0781NabumetoneNabumetone
    71335-0531NabumetoneNabumetone
    71335-0754NabumetoneNabumetone
    71335-0939NabumetoneNabumetone
    76282-258NabumetoneNabumetone
    76282-257NabumetoneNabumetone
    43063-859NabumetoneNabumetone
    45865-351NabumetoneNabumetone

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