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 ID | 58602-803_08c50304-67d6-4733-84e4-5a686afa04f3 |
NDC | 58602-803 |
Product Type | Human Otc Drug |
Proprietary Name | Ibuprofen and Pseudoephedrine HCl |
Generic Name | Ibuprofen And Pseudoephedrine Hcl |
Dosage Form | Capsule, Liquid Filled |
Route of Administration | ORAL |
Marketing Start Date | 2017-12-01 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA209235 |
Labeler Name | Aurohealth LLC |
Substance Name | IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE |
Active Ingredient Strength | 200 mg/1; mg/1 |
Pharm Classes | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2020-01-17 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2017-12-01 |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2017-12-01 |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2020-01-17 |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2019-10-22 |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2017-12-01 |
Marketing Category | ANDA |
Application Number | ANDA209235 |
Product Type | HUMAN OTC DRUG |
Marketing Start Date | 2017-12-01 |
Ingredient | Strength |
---|---|
IBUPROFEN | 200 mg/1 |
SPL SET ID: | 6adf9292-b4af-4cb4-99f3-dda03734570a |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI | |
PHarm Class EPC | |
NUI Code |
NDC | Brand Name | Generic Name |
---|---|---|
0363-1106 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl |
46122-609 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl |
58602-803 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl |
69842-092 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl |
70000-0606 | Ibuprofen and Pseudoephedrine HCl | Ibuprofen and Pseudoephedrine HCl |