NDC 58487-001

DURLAZA

Acetylsalicylic Acid

DURLAZA is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by New Haven Pharmaceuticals, Inc.. The primary component is Aspirin.

• Product ID: 58487-001_6461fd18-6b4d-809a-73f4-fd0c23a99291
• NDC: 58487-001
• Product Type: Human Prescription Drug
• Proprietary Name: DURLAZA
• Generic Name: Acetylsalicylic Acid
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-09-25
• Marketing Category: NDA / NDA
• Application Number: NDA200671
• Labeler Name: New Haven Pharmaceuticals, Inc.
• Substance Name: ASPIRIN
• Active Ingredient Strength: 163 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 58487-001-02

90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58487-001-02)

• Marketing Start Date: 2015-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58487-001-02 [58487000102]

DURLAZA CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200671
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-25
• Inactivation Date: 2020-01-31

NDC 58487-001-01 [58487000101]

DURLAZA CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA200671
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	162.5 mg/1

OpenFDA Data

• SPL SET ID: 4c2a1403-3862-1efd-0a91-444989222b37
• Manufacturer:
  • New Haven Pharmaceuticals, Inc.
• UNII:
  • R16CO5Y76E
• RxNorm Concept Unique ID - RxCUI:
  • 1665362
  • 1665356
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

Pharmacological Class

• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Platelet Aggregation Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]

NDC Crossover Matching brand name "DURLAZA" or generic name "Acetylsalicylic Acid"

NDC	Brand Name	Generic Name
58487-001	DURLAZA	Acetylsalicylic Acid
73678-160	Biovanta Double Action	Acetylsalicylic Acid