NDC 70518-0653

Loratadine and Pseudoephedrine

Loratadine And Pseudoephedrine

Loratadine and Pseudoephedrine is a Oral Tablet, Extended Release in the Human Otc Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Loratadine; Pseudoephedrine Sulfate.

• Product ID: 70518-0653_55a2ff2e-bbe4-6e8f-e054-00144ff8d46c
• NDC: 70518-0653
• Product Type: Human Otc Drug
• Proprietary Name: Loratadine and Pseudoephedrine
• Generic Name: Loratadine And Pseudoephedrine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-07-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076557
• Labeler Name: REMEDYREPACK INC.
• Substance Name: LORATADINE; PSEUDOEPHEDRINE SULFATE
• Active Ingredient Strength: 10 mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0653-0

5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-0653-0)

• Marketing Start Date: 2017-07-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0653-0 [70518065300]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076557
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-07-31
• Marketing End Date: 2020-04-30

Drug Details

Active Ingredients

Ingredient	Strength
LORATADINE	10 mg/1

OpenFDA Data

• SPL SET ID: af51f2ae-6f90-4cac-96e9-5faed3b07847
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • Y9DL7QPE6B
  • 7AJO3BO7QN
• RxNorm Concept Unique ID - RxCUI:
  • 1117562

NDC Crossover Matching brand name "Loratadine and Pseudoephedrine" or generic name "Loratadine And Pseudoephedrine"

NDC	Brand Name	Generic Name
0363-0725	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine
11822-9990	Loratadine and Pseudoephedrine	LORATADINE and PSEUDOEPHEDRINE SULFATE
21695-729	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
41163-165	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine
46122-383	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
51660-488	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
51660-491	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
51660-724	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
61715-016	Loratadine and Pseudoephedrine	Loratadine and Pseudoephedrine
63187-305	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
63629-7766	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
70518-0653	Loratadine and Pseudoephedrine	loratadine and pseudoephedrine
59779-726	ALLERGY RELIEF-D	Loratadine and Pseudoephedrine