ogivri
Generic: trastuzumab-dkst
Labeler: biocon biologics inc.Drug Facts
Product Profile
Brand Name
ogivri
Generic Name
trastuzumab-dkst
Labeler
biocon biologics inc.
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
Active Ingredients
trastuzumab 420 mg/20mL
Manufacturer
Identifiers & Regulatory
Product NDC
83257-003
Product ID
83257-003_ef07d382-d369-dfad-1491-3a4cc3b57d01
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
BLA
Application Number
BLA761074
Listing Expiration
2026-12-31
Marketing Start
2023-10-01
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
83257003
Hyphenated Format
83257-003
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
ogivri (source: ndc)
Generic Name
trastuzumab-dkst (source: ndc)
Application Number
BLA761074 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 420 mg/20mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Ogivri (trastuzumab-dkst) for injection 420 mg/vial is supplied in a multiple-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial of Ogivri and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative. NDC 83257-004-12 Ogivri (trastuzumab-dkst) for injection 420 mg/vial is supplied in a multiple-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial of Ogivri. No diluent is provided. NDC 83257-003-01 Ogivri (trastuzumab-dkst) for injection 150 mg/vial is supplied in a single-dose vial as an off-white to pale yellow lyophilized sterile powder, under vacuum. Each carton contains one single-dose vial of Ogivri. NDC 83257-001-11 Store Ogivri vials in the refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution.
- PRINCIPAL DISPLAY PANEL - 420 mg/vial with Diluent NDC 83257-004-12 Rx only Ogivri ® (trastuzumab-dkst) For Injection 420 mg/vial For intravenous infusion after reconstitution No preservative KEEP REFRIGERATED Multiple-Dose Vial Contents: Each carton contains one 420 mg vial of Ogivri and one vial containing 20 mL of Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol). The content of each Ogivri ® vial is 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), L-Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. No U.S. standard of potency. Bacteriostatic Water for Injection, USP is a sterile water containing 1.1% benzyl alcohol as an antimicrobial preservative packaged in a multi-use vial. The diluent is pH 4.5 to 7. Store in refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution. Reconstitution, Dosage, and Administration: Do not use if vacuum is not present. See prescribing information for dosage, preparation, and administration. Reconstitute with 20 mL Bacteriostatic Water for Injection (BWFI), USP (0.9% to 1.1% benzyl alcohol) to yield a multiple-dose solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst). Do Not Shake. Store reconstituted solution in refrigerator at 2° to 8°C (36° to 46°F). Do not Freeze. Discard unused reconstituted solution after 28 days. Do Not Freeze. Do Not Shake Reconstituted Solution. KEEP REFRIGERATED Ogivri ® and the Ogivri Logo are registered trademarks of Biosimilars New Co. Ltd.; a Biocon Biologics Company. Copyright © 2023 Biocon Biologics Inc. All rights reservedy. Manufactured by: Biocon Biologics Inc. 245 Main st, 2nd floor Cambridge, MA 02142, U.S.A. U.S Licence No. 2324 Product of India KR/DRUGS/KTK/28D/07/2006
- PRINCIPAL DISPLAY PANEL -150 mg/vial NDC 83257-001-11 Rx Only Ogivri ® (trastuzumab-dkst) For Injection 150 mg/vial For intravenous infusion after reconstitution No preservative KEEP REFRIGERATED Single-Dose Vial Discard Unused Portion The content of each Ogivri ® vial is 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. No U.S. standard of potency. Usual dosage: See package insert for dosage, preparation, and administration information. Storage: Refrigerate at 2° to 8°C (36° to 46°F) until time of reconstitution. Reconstitute immediately before use. Do Not Freeze. Do Not Shake After Reconstitution. Ogivri ® & the Ogivri Logo are registered trademarks of Biosimilars New Co. Ltd.; a Biocon Biologics Company. Copyright © 2023 Biocon Biologics Inc. All rights reserved. Manufactured by: Biocon Biologics Inc. 245 Main st, 2nd floor Cambridge, MA 02142, U.S.A U.S Licence No. 2324 Product of India KR/DRUGS/KTK/28D/07/2006
- PRINCIPAL DISPLAY PANEL -420 mg/vial NDC 83257-003-01 Rx only Ogivri ® (trastuzumab-dkst)For Injection420 mg/vial For intravenous infusion after reconstitution No preservative KEEP REFRIGERATED Multiple-DoseVial Contents: Each carton contains one 420 mg vial of Ogivri. The content of each Ogivri ® vial is 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), L-Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg). Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. No U.S. standard of potency. Store in refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution. Reconstitution, Dosage, and Administration: Do not use if vacuum is not present. See prescribing information for dosage, preparation, and administration. Reconstitute with 20 mL Bacteriostatic Water for Injection (BWFI), USP (0.9% to 1.1% benzyl alcohol) to yield a multiple-dose solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst). Do Not Shake. Store reconstituted solution in refrigerator at 2° to 8°C (36° to 46°F). Do not Freeze. Discard unused reconstituted solution after 28 days. Do Not Freeze. Do Not Shake Reconstituted Solution. KEEP REFRIGERATED Ogivri ® & the Ogivri Logo are registered trademarks of Biosimilars New Co. Ltd.; a Biocon Biologics Company. Copyright © 2023 Biocon Biologics Inc. All rights reserved. Manufactured by: Biocon Biologics Inc. 245 Main st, 2nd floor Cambridge, MA 02142, U.S.A.U.S Licence No. 2324 Product of India KR/DRUGS/KTK/28D/07/2006
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ef07d382-d369-dfad-1491-3a4cc3b57d01", "openfda": {"nui": ["N0000175661", "N0000020008"], "upc": ["0383257001113"], "unii": ["P188ANX8CK"], "rxcui": ["2179753", "2179758", "2179760", "2179763"], "spl_set_id": ["b6465b44-a6dd-f99c-d009-6851cf05169c"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "OGIVRI", "product_id": "83257-003_ef07d382-d369-dfad-1491-3a4cc3b57d01", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "83257-003", "generic_name": "trastuzumab-dkst", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OGIVRI", "active_ingredients": [{"name": "TRASTUZUMAB", "strength": "420 mg/20mL"}], "application_number": "BLA761074", "marketing_category": "BLA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}