NDC 61919-621

IBU

Ibu

IBU is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Ibuprofen.

Product ID61919-621_281fdc28-fe10-3a47-e054-00144ff88e88
NDC61919-621
Product TypeHuman Prescription Drug
Proprietary NameIBU
Generic NameIbu
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA075682
Labeler NameDirectRX
Substance NameIBUPROFEN
Active Ingredient Strength800 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-621-72

120 TABLET in 1 BOTTLE (61919-621-72)
Marketing Start Date2019-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-621-90 [61919062190]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-29

NDC 61919-621-21 [61919062121]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-20

NDC 61919-621-60 [61919062160]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-20

NDC 61919-621-15 [61919062115]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-20

NDC 61919-621-72 [61919062172]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-20

NDC 61919-621-71 [61919062171]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-30
Inactivation Date2020-01-31

NDC 61919-621-40 [61919062140]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-26

NDC 61919-621-30 [61919062130]

IBUPROFEN TABLET
Marketing CategoryANDA
Application NumberANDA075682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN800 mg/1

OpenFDA Data

SPL SET ID:281fdc28-fe0f-3a47-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197807
  • 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]

    NDC Crossover Matching brand name "IBU" or generic name "Ibu"

    NDCBrand NameGeneric Name
    0615-8115IBUIbuprofen
    0615-8116IBUIbuprofen
    0615-8117IBUIbuprofen
    10544-071IBUIbuprofen
    10544-625IBUIbuprofen
    35356-699IBUIbuprofen
    43353-273IBUIbuprofen
    49999-042IBUIbuprofen
    50090-4331IBUIbuprofen
    50090-4333IBUIbuprofen
    50090-4339IBUIbuprofen
    50090-4341IBUIbuprofen
    50436-0684IBUIbuprofen
    50436-4604IBUIbuprofen
    50436-4605IBUIbuprofen
    51407-369IBUIbuprofen
    51407-370IBUIbuprofen
    51407-371IBUIbuprofen
    53002-3010IBUIbuprofen
    53002-3370IBUIbuprofen
    53002-3980IBUIbuprofen
    53217-366IBUIbuprofen
    55111-682IBUIbuprofen
    55111-683IBUIbuprofen
    55111-684IBUIbuprofen
    60429-219IBUIbuprofen
    60429-220IBUIbuprofen
    60429-221IBUIbuprofen
    60760-076IBUIbuprofen
    60760-135IBUIbuprofen
    61919-621IBUIBU
    68071-1827IBUIBU
    68071-3053IBUIBU
    68071-3125IBUIBU
    68071-3172IBUIBU
    70518-0490IBUIBU
    70518-1145IBUIBU
    63187-614IBUIBU
    66267-116IBUIBU
    66267-117IBUIBU
    66267-963IBUIBU
    66267-793IBUIBU
    66267-795IBUIBU
    66267-964IBUIBU
    66267-794IBUIBU
    67296-1217IBUIBU
    67296-0877IBUIBU
    67296-0913IBUIBU
    70934-195IBUIBU
    71610-275IBUIBU

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