NDC 52244-404

SEMPREX D

Acrivastine And Pseudoephedrine Hydrochloride

SEMPREX D is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals Inc.. The primary component is Acrivastine; Pseudoephedrine Hydrochloride.

• Product ID: 52244-404_21d2a8a6-108c-4c1d-b1ee-c14f6f2dadc6
• NDC: 52244-404
• Product Type: Human Prescription Drug
• Proprietary Name: SEMPREX D
• Generic Name: Acrivastine And Pseudoephedrine Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2012-01-26
• Marketing End Date: 2020-12-31
• Marketing Category: NDA / NDA
• Application Number: NDA019806
• Labeler Name: Endo Pharmaceuticals Inc.
• Substance Name: ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N

Packaging

NDC 52244-404-10

100 CAPSULE in 1 BOTTLE, PLASTIC (52244-404-10)

• Marketing Start Date: 2012-01-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52244-404-10 [52244040410]

SEMPREX D CAPSULE

• Marketing Category: NDA
• Application Number: NDA019806
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-26

Drug Details

Active Ingredients

Ingredient	Strength
ACRIVASTINE	8 mg/1

OpenFDA Data

• SPL SET ID: d86c6a13-9e5f-43c2-92f5-c7ed7bfcedfc
• Manufacturer:
  • Endo Pharmaceuticals, Inc.
• UNII:
  • 6V9V2RYJ8N
  • A20F9XAI7W
• RxNorm Concept Unique ID - RxCUI:
  • 1112244
  • 1112246
• UPC Code:
  • 0352244404107

Pharmacological Class

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]
• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]
• Adrenergic alpha-Agonists [MoA]
• alpha-Adrenergic Agonist [EPC]

Medicade Reported Pricing

52244040410 SEMPREX-D 8 MG-60 MG CAPSULE

Pricing Unit: EA | Drug Type: