NDC 63629-7766

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 Bryant Ranch Prepack. The primary component is Loratadine; Pseudoephedrine Sulfate.

• Product ID: 63629-7766_12559602-c87a-4726-8e38-cf5cfcc93b82
• NDC: 63629-7766
• 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: 2004-11-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076557
• Labeler Name: Bryant Ranch Prepack
• Substance Name: LORATADINE; PSEUDOEPHEDRINE SULFATE
• Active Ingredient Strength: 10 mg/1; mg/1
• Pharm Classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 63629-7766-1

5 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7766-1)

• Marketing Start Date: 2021-12-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63629-7766-3 [63629776603]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076557
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-05

NDC 63629-7766-1 [63629776601]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076557
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2007-08-29

NDC 63629-7766-2 [63629776602]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076557
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2007-08-29

Drug Details

Active Ingredients

Ingredient	Strength
LORATADINE	10 mg/1

OpenFDA Data

• SPL SET ID: 12559602-c87a-4726-8e38-cf5cfcc93b82
• Manufacturer:
  • Bryant Ranch Prepack
• 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