NDC 0006-5033

Ontruzant

Trastuzumab

Ontruzant is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Trastuzumab.

• Product ID: 0006-5033_251cf6e9-46e5-419e-bbbc-12c914ccc7fc
• NDC: 0006-5033
• Product Type: Human Prescription Drug
• Proprietary Name: Ontruzant
• Generic Name: Trastuzumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-04-15
• Marketing Category: BLA / BLA
• Application Number: BLA761100
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: TRASTUZUMAB
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-5033-02

1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5033-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0006-5033-01)

• Marketing Start Date: 2020-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-5033-02 [00006503302]

Ontruzant INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761100
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-15

NDC 0006-5033-01 [00006503301]

Ontruzant INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761100
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-15

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB	150 mg/1

OpenFDA Data

• SPL SET ID: a8d34591-b709-492b-84e3-d7764db9366a
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • P188ANX8CK
• RxNorm Concept Unique ID - RxCUI:
  • 2289232
  • 2289234
  • 2289237
  • 2289227
• UPC Code:
  • 0300065034027

Pharmacological Class

• HER2/neu Receptor Antagonist [EPC]
• HER2/Neu/cerbB2 Antagonists [MoA]

NDC Crossover Matching brand name "Ontruzant" or generic name "Trastuzumab"

NDC	Brand Name	Generic Name
0006-5033	Ontruzant	trastuzumab
0006-5034	Ontruzant	Ontruzant
50242-132	Herceptin	Trastuzumab
50242-134	Herceptin	Trastuzumab
50242-333	Herceptin	Trastuzumab
63459-303	HERZUMA	TRASTUZUMAB
63459-305	HERZUMA	TRASTUZUMAB
67457-845	OGIVRI	trastuzumab
67457-847	OGIVRI	trastuzumab
67457-991	OGIVRI	trastuzumab
0069-0305	Trazimera-qyyp	trastuzumab