FDA.reportPublic FDA data

OCREVUS

Product NDC
50242-150
11-digit product format
502420150
Labeler code
50242
Product ID
50242-150_00b80381-c728-47a0-bd9e-b1223a1c0a40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ocrelizumab
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA761053
Marketing category
BLA
Marketing start
2017-03-28
Substance
OCRELIZUMAB
Active strength
300 mg/10mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OCREVUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCRELIZUMAB300 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A10SJL62JYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1876380Internal RxNorm lookup
1876385Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9da42362-3bb5-4b83-b4bb-b59fd4e55f0dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
0370057a-6e63-432c-842f-2aeb7aad1b53Product name120170613
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-150-01OCREVUS1 in 1 CARTONINJECTION124
50242-150-01OCREVUS10 mL in 1 VIAL, SINGLE-USEINJECTION1024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-150-01ML - Milliliter50242-15011f5fe6a-a952-484b-b19d-227b579e2c4112017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-150OCREVUS (OCRELIZUMAB) INJECTION [GENENTECH, INC.]19Current NDC, Legacy NDC, 2 package rows20241127_9da42362-3bb5-4b83-b4bb-b59fd4e55f0d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OCREVUSOCRELIZUMABGenentech, Inc.9da42362-3bb5-4b83-b4bb-b59fd4e55f0d2026-05-14Warnings, Adverse reactionsExact identifier
application number: BLA761053
ndc (product): 50242-150

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761053Ocrevusocrelizumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1876380ocrelizumab 300 MG in 10 ML InjectionPSN9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
1876385Ocrevus 300 MG in 10 ML InjectionPSN9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
187638510 ML ocrelizumab 30 MG/ML Injection [Ocrevus]SBD9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
187638010 ML ocrelizumab 30 MG/ML InjectionSCD9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
187638510 ML Ocrevus 30 MG/ML InjectionSY9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
1876380ocrelizumab 300 MG per 10 ML InjectionSY9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24
1876385Ocrevus 300 MG per 10 ML InjectionSY9da42362-3bb5-4b83-b4bb-b59fd4e55f0d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-150-01502420150011 VIAL, SINGLE-USE in 1 CARTON (50242-150-01) / 10 mL in 1 VIAL, SINGLE-USE2017-03-280000-00-00NoNoCurrent