NDC 0485-0206
RYNEX PSE
Brompheniramine Maleate And Pseudoephedrine Hydrochloride
RYNEX PSE is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Brompheniramine Maleate; Pseudoephedrine Hydrochloride.
| Product ID | 0485-0206_19ac8a3a-6e5f-4c5d-93f0-9aba74ef22f6 |
| NDC | 0485-0206 |
| Product Type | Human Otc Drug |
| Proprietary Name | RYNEX PSE |
| Generic Name | Brompheniramine Maleate And Pseudoephedrine Hydrochloride |
| Dosage Form | Liquid |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-03-07 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
| Substance Name | BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/5mL; mg/5mL |
| Pharm Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0485-0206-16
473 mL in 1 BOTTLE, PLASTIC (0485-0206-16)
| Marketing Start Date | 2011-03-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0485-0206-16 [00485020616]
RYNEX PSE LIQUID
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-07 |
| Inactivation Date | 2020-01-31 |
| Reactivation Date | 2020-04-08 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BROMPHENIRAMINE MALEATE | 1 mg/5mL |
OpenFDA Data
| SPL SET ID: | 2f2d9b5a-f66b-4928-8d43-402ef9efcfdf |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
NDC Crossover Matching brand name "RYNEX PSE" or generic name "Brompheniramine Maleate And Pseudoephedrine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0485-0206 | RYNEX PSE | BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE |
| 54838-125 | Brotapp | Brompheniramine maleate and Pseudoephedrine hydrochloride |
| 0095-0860 | Lodrane D | brompheniramine maleate and pseudoephedrine hydrochloride |
| 68788-9184 | Q-Tapp | Brompheniramine maleate and Pseudoephedrine hydrochloride |
| 0485-0202 | RYNEX PE | BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE |
Trademark Results [RYNEX PSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RYNEX PSE 86287513 4698725 Live/Registered |
Edwards Pharmaceuticals, Inc. 2014-05-21 |
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