NDC 15370-170

RELAFEN DS

Nabumetone

RELAFEN DS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Carwin Pharmaceutical Associates, Llc. The primary component is Nabumetone.

Product ID15370-170_00f18a4b-1509-41fb-8e01-12bfb58f9cca
NDC15370-170
Product TypeHuman Prescription Drug
Proprietary NameRELAFEN DS
Generic NameNabumetone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-09-20
Marketing CategoryANDA / ANDA
Application NumberANDA203166
Labeler NameCarwin Pharmaceutical Associates, LLC
Substance NameNABUMETONE
Active Ingredient Strength1000 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 15370-170-10

100 TABLET in 1 BOTTLE, PLASTIC (15370-170-10)
Marketing Start Date2022-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15370-170-60 [15370017060]

RELAFEN DS TABLET
Marketing CategoryANDA
Application NumberANDA203166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-28

NDC 15370-170-99 [15370017099]

RELAFEN DS TABLET
Marketing CategoryANDA
Application NumberANDA203166
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-28

NDC 15370-170-30 [15370017030]

RELAFEN DS TABLET
Marketing CategoryANDA
Application NumberANDA203166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-20

Drug Details

Active Ingredients

IngredientStrength
NABUMETONE1000 mg/1

OpenFDA Data

SPL SET ID:a9a0af85-6c43-4a2d-ba75-0be4ca64c931
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 427726
  • 2200291
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • UPC Code
  • 0315370170308
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • Pharmacological Class

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

    NDC Crossover Matching brand name "RELAFEN DS" or generic name "Nabumetone"

    NDCBrand NameGeneric Name
    15370-170RELAFEN DSNABUMETONE
    0115-1657NabumetoneNabumetone
    0115-1658NabumetoneNabumetone
    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
    35356-686NabumetoneNabumetone
    35356-687NabumetoneNabumetone
    35356-726NabumetoneNabumetone
    43063-859NabumetoneNabumetone
    0722-7078Nabumetone 1000 mgNabumetone
    0722-7076Nabumetone 500 mgNabumetone
    0722-7077Nabumetone 750 mgNabumetone

    Trademark Results [RELAFEN DS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RELAFEN DS
    RELAFEN DS
    87333917 5944501 Live/Registered
    Argent Development Group, LLC
    2017-02-13
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