NDC 0485-0210

ED-A-HIST PSE

Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride

ED-A-HIST PSE is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Pseudoephedrine Hydrochloride; Triprolidine Hydrochloride.

• Product ID: 0485-0210_5a2b4ef1-6705-433d-aeb3-6ddd1c204d9c
• NDC: 0485-0210
• Product Type: Human Otc Drug
• Proprietary Name: ED-A-HIST PSE
• Generic Name: Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-10-08
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: EDWARDS PHARMACEUTICALS, INC.
• Substance Name: PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0485-0210-01

100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0210-01)

• Marketing Start Date: 2011-10-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0210-01 [00485021001]

ED-A-HIST PSE TABLET, COATED

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-08
• Marketing End Date: 2020-04-01
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-08

Drug Details

Active Ingredients

Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: b0c6ef78-0f82-4ff7-a988-b11f99094843
• Manufacturer:
  • EDWARDS PHARMACEUTICALS, INC.
• UNII:
  • 6V9V2RYJ8N
  • YAN7R5L890
• RxNorm Concept Unique ID - RxCUI:
  • 1099446
• UPC Code:
  • 3004850210012

NDC Crossover Matching brand name "ED-A-HIST PSE" or generic name "Pseudoephedrine Hydrochloride And Triprolidine Hydrochloride"

NDC	Brand Name	Generic Name
0485-0210	ED-A-HIST PSE	PSEUDOEPHEDRINE HYDROCHLORIDE and TRIPROLIDINE HYDROCHLORIDE
58605-305	Maxi-Tuss TR	Pseudoephedrine Hydrochloride and Triprolidine Hydrochloride
58605-106	Maxifed TR	pseudoephedrine hydrochloride and triprolidine hydrochloride
54838-101	Silafed	Pseudoephedrine hydrochloride and Triprolidine hydrochloride