NDC 0363-0423

Ibuprofen and Pseudoephedrine Hydrochloride

Ibuprofen And Pseudoephedrine Hydrochloride

Ibuprofen and Pseudoephedrine Hydrochloride is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Walgreen Company. The primary component is Ibuprofen; Pseudoephedrine Hydrochloride.

Product ID0363-0423_28d9145e-3aa3-4a6e-97d4-591a5ff16be9
NDC0363-0423
Product TypeHuman Otc Drug
Proprietary NameIbuprofen and Pseudoephedrine Hydrochloride
Generic NameIbuprofen And Pseudoephedrine Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2017-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA074567
Labeler NameWALGREEN COMPANY
Substance NameIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1
Pharm ClassesAdrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0363-0423-21

20 TABLET, COATED in 1 BLISTER PACK (0363-0423-21)
Marketing Start Date2017-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0363-0423-41 [00363042341]

Ibuprofen and Pseudoephedrine Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA074567
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-08-01
Inactivation Date2020-01-31

NDC 0363-0423-21 [00363042321]

Ibuprofen and Pseudoephedrine Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA074567
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-08-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:c3b302c6-a2d2-491c-8f56-ecc25dd1f6c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299021
    • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
    • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721

    • NDC Crossover Matching brand name "Ibuprofen and Pseudoephedrine Hydrochloride" or generic name "Ibuprofen And Pseudoephedrine Hydrochloride"

    NDCBrand NameGeneric Name
    0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    11673-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    11822-0084Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    21130-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    30142-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    36800-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    37808-324Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    37808-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    41250-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    49348-097Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    51660-423Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochloride
    51660-490Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    51660-493Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochloride
    53943-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    56062-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    59779-430Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    62011-0070Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    63629-5284Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochloride
    63868-453Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    68016-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine Hydrochloride
    70000-0602IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE
    0573-0180ADVIL COLD AND SINUSibuprofen and pseudoephedrine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.