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 |