NDC 0003-0011

DAKLINZA

Daclatasvir

DAKLINZA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by E.r. Squibb & Sons, L.l.c.. The primary component is Daclatasvir Dihydrochloride.

• Product ID: 0003-0011_780ae42b-9b05-4a02-9529-5e45dbb460f6
• NDC: 0003-0011
• Product Type: Human Prescription Drug
• Proprietary Name: DAKLINZA
• Generic Name: Daclatasvir
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-18
• Marketing End Date: 2019-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA206843
• Labeler Name: E.R. Squibb & Sons, L.L.C.
• Substance Name: DACLATASVIR DIHYDROCHLORIDE
• Active Ingredient Strength: 90 mg/1
• Pharm Classes: Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0003-0011-01

28 TABLET in 1 BOTTLE (0003-0011-01)

• Marketing Start Date: 2016-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0003-0011-01 [00003001101]

DAKLINZA TABLET

• Marketing Category: NDA
• Application Number: NDA206843
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-05-18
• Marketing End Date: 2019-04-30

Drug Details

Active Ingredients

Ingredient	Strength
DACLATASVIR DIHYDROCHLORIDE	90 mg/1

OpenFDA Data

• SPL SET ID: 9803a6ff-8a3e-4c64-b3d0-7825c7123bf2
• Manufacturer:
  • E.R. Squibb & Sons, L.L.C.
• UNII:
  • 50ZO25C11D
• RxNorm Concept Unique ID - RxCUI:
  • 1660191
  • 1793882
  • 1793884
  • 1660194
  • 1660185
  • 1660196

Pharmacological Class

• Hepatitis C Virus NS5A Inhibitor [EPC]
• P-Glycoprotein Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Breast Cancer Resistance Protein Inhibitors [MoA]

NDC Crossover Matching brand name "DAKLINZA" or generic name "Daclatasvir"

NDC	Brand Name	Generic Name
0003-0011	DAKLINZA	daclatasvir
0003-0213	DAKLINZA	daclatasvir
0003-0215	DAKLINZA	daclatasvir