NDC 63187-305

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 Proficient Rx Lp. The primary component is Loratadine; Pseudoephedrine Sulfate.

• Product ID: 63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed
• NDC: 63187-305
• 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: Proficient Rx LP
• Substance Name: LORATADINE; PSEUDOEPHEDRINE SULFATE
• Active Ingredient Strength: 10 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63187-305-10

1 BLISTER PACK in 1 CARTON (63187-305-10) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2015-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63187-305-10 [63187030510]

Loratadine and Pseudoephedrine TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076557
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-03-01

Drug Details

Active Ingredients

Ingredient	Strength
LORATADINE	10 mg/1

OpenFDA Data

• SPL SET ID: ca1a6552-d082-4312-ba17-0055e8554eb9
• Manufacturer:
  • Proficient Rx LP
• 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