NDC 70000-0518

12HR Allergy and Congestion Relief

Fexofenadine Hcl And Pseudoephedrine Hci

12HR Allergy and Congestion Relief is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Cardinal Health. The primary component is Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride.

• Product ID: 70000-0518_27318205-3894-fa6e-677b-a8fbd850bd04
• NDC: 70000-0518
• Product Type: Human Otc Drug
• Proprietary Name: 12HR Allergy and Congestion Relief
• Generic Name: Fexofenadine Hcl And Pseudoephedrine Hci
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-10-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076667
• Labeler Name: Cardinal Health
• Substance Name: FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 60 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70000-0518-1

4 BLISTER PACK in 1 CARTON (70000-0518-1) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2019-10-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70000-0518-1 [70000051801]

12HR Allergy and Congestion Relief TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076667
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-10-08

Drug Details

Active Ingredients

Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	60 mg/1

OpenFDA Data

• SPL SET ID: 85e8f580-0b05-81cf-5e0f-f5a176e82766
• Manufacturer:
  • Cardinal Health
• UNII:
  • 6V9V2RYJ8N
  • 2S068B75ZU
• RxNorm Concept Unique ID - RxCUI:
  • 997406

NDC Crossover Matching brand name "12HR Allergy and Congestion Relief" or generic name "Fexofenadine Hcl And Pseudoephedrine Hci"

NDC	Brand Name	Generic Name
70000-0518	12HR Allergy and Congestion Relief	Fexofenadine HCl and Pseudoephedrine HCI
11822-7388	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI
62011-0455	Allergy and Congestion	Fexofenadine HCl and Pseudoephedrine HCI
0363-0448	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
0363-1606	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
0536-1242	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
11673-032	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
21130-557	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
30142-447	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
30142-611	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
37808-022	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
43598-823	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
49035-273	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
55111-447	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
55111-557	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
59779-508	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI
69842-249	Fexofenadine HCl and Pseudoephedrine HCI	Fexofenadine HCl and Pseudoephedrine HCI