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 Identifiers#

Field, Values table
FieldValues
UniiA10SJL62JY
Rxcui1876380, 1876385

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

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