NDC 63629-5284

Ibuprofen and Pseudoephedrine hydrochloride

Ibuprofen And Pseudoephedrine Hydrochloride

Ibuprofen and Pseudoephedrine hydrochloride is a Oral Tablet, Sugar Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Ibuprofen; Pseudoephedrine Hydrochloride.

Product ID63629-5284_7249b0f9-b24c-4f7f-81f2-22473a4d5b0c
NDC63629-5284
Product TypeHuman Prescription Drug
Proprietary NameIbuprofen and Pseudoephedrine hydrochloride
Generic NameIbuprofen And Pseudoephedrine Hydrochloride
Dosage FormTablet, Sugar Coated
Route of AdministrationORAL
Marketing Start Date2001-10-13
Marketing CategoryANDA / ANDA
Application NumberANDA074567
Labeler NameBryant Ranch Prepack
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 63629-5284-1

30 TABLET, SUGAR COATED in 1 BOTTLE (63629-5284-1)
Marketing Start Date2022-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-5284-2 [63629528402]

Ibuprofen and Pseudoephedrine hydrochloride TABLET, SUGAR COATED
Marketing CategoryANDA
Application NumberANDA074567
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-10-13
Inactivation Date2019-11-27

NDC 63629-5284-1 [63629528401]

Ibuprofen and Pseudoephedrine hydrochloride TABLET, SUGAR COATED
Marketing CategoryANDA
Application NumberANDA074567
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-10-13
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:7249b0f9-b24c-4f7f-81f2-22473a4d5b0c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299021
  • 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]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

    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.