FDA.reportPublic FDA data

CINQAIR

Product NDC
59310-610
11-digit product format
593100610
Labeler code
59310
Product ID
59310-610_a509df2c-67b6-40c3-8b6d-f9de54b62c8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Reslizumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Respiratory, LLC
Application
BLA761033
Marketing category
BLA
Marketing start
2016-04-18
Substance
RESLIZUMAB
Active strength
10 mg/mL
Pharmacologic classes
Interleukin-5 Antagonist [EPC], Interleukin-5 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59310-61059310-610-33DDiscontinued by firm2026-08-17

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RESLIZUMAB10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35A26E427HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1746893Internal RxNorm lookup
1746898Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
053b9158-2a5b-48b9-bf47-5fa78a35ec33Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
a17bade7-6894-4748-a302-8650419174e2Product name120160504
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
59310-610-31CINQAIR10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE1014
59310-610-31CINQAIR1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE114
59310-610-33CINQAIR10 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE1014
59310-610-33CINQAIR1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59310-610-31ML - Milliliter59310-610779e830e-6849-4cad-a1e6-bfcad76ebad412016-05-16
59310-610-33ML - Milliliter59310-6107b0966eb-0c99-49fb-abb0-beb0216249c412022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59310-610CINQAIR (RESLIZUMAB) INJECTION, SOLUTION, CONCENTRATE [TEVA RESPIRATORY, LLC]10Current NDC, Legacy NDC, 4 package rows20200630_053b9158-2a5b-48b9-bf47-5fa78a35ec33.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
CINQAIRRESLIZUMABTeva Respiratory, LLC053b9158-2a5b-48b9-bf47-5fa78a35ec332020-02-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761033
ndc (product): 59310-610

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761033Cinqairreslizumab351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1746898CINQAIR 100 MG in 10 ML InjectionPSN053b9158-2a5b-48b9-bf47-5fa78a35ec3314
1746893reslizumab 100 MG in 10 ML InjectionPSN053b9158-2a5b-48b9-bf47-5fa78a35ec3314
174689810 ML reslizumab 10 MG/ML Injection [Cinqair]SBD053b9158-2a5b-48b9-bf47-5fa78a35ec3314
174689310 ML reslizumab 10 MG/ML InjectionSCD053b9158-2a5b-48b9-bf47-5fa78a35ec3314
174689810 ML Cinqair 10 MG/ML InjectionSY053b9158-2a5b-48b9-bf47-5fa78a35ec3314
1746898Cinqair 100 MG per 10 ML InjectionSY053b9158-2a5b-48b9-bf47-5fa78a35ec3314
1746893reslizumab 100 MG per 10 ML InjectionSY053b9158-2a5b-48b9-bf47-5fa78a35ec3314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59310-610-31593100610311 VIAL, SINGLE-USE in 1 CARTON (59310-610-31) / 10 mL in 1 VIAL, SINGLE-USE2016-04-180000-00-00NoNoCurrent
59310-610-33593100610331 VIAL, SINGLE-USE in 1 CARTON (59310-610-33) > 10 mL in 1 VIAL, SINGLE-USE2017-06-040000-00-00YesNoCurrent