NDC 58602-803

Ibuprofen and Pseudoephedrine HCl

Ibuprofen And Pseudoephedrine Hcl

Ibuprofen and Pseudoephedrine HCl is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Aurohealth Llc. The primary component is Ibuprofen; Pseudoephedrine Hydrochloride.

Product ID58602-803_08c50304-67d6-4733-84e4-5a686afa04f3
NDC58602-803
Product TypeHuman Otc Drug
Proprietary NameIbuprofen and Pseudoephedrine HCl
Generic NameIbuprofen And Pseudoephedrine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA209235
Labeler NameAurohealth LLC
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 58602-803-03

1 BLISTER PACK in 1 CARTON (58602-803-03) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (58602-803-83)
Marketing Start Date2020-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58602-803-13 [58602080313]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-01

NDC 58602-803-67 [58602080367]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-01

NDC 58602-803-03 [58602080303]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-17

NDC 58602-803-79 [58602080379]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-22

NDC 58602-803-08 [58602080308]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-01

NDC 58602-803-83 [58602080383]

Ibuprofen and Pseudoephedrine HCl CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA209235
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:6adf9292-b4af-4cb4-99f3-dda03734570a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299018
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Ibuprofen and Pseudoephedrine HCl" or generic name "Ibuprofen And Pseudoephedrine Hcl"

    NDCBrand NameGeneric Name
    0363-1106Ibuprofen and Pseudoephedrine HClIbuprofen and Pseudoephedrine HCl
    46122-609Ibuprofen and Pseudoephedrine HClIbuprofen and Pseudoephedrine HCl
    58602-803Ibuprofen and Pseudoephedrine HClIbuprofen and Pseudoephedrine HCl
    69842-092Ibuprofen and Pseudoephedrine HClIbuprofen and Pseudoephedrine HCl
    70000-0606Ibuprofen and Pseudoephedrine HClIbuprofen and Pseudoephedrine HCl

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