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

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 Identifiers#

Field, Values table
FieldValues
Unii35A26E427H
Rxcui1746893, 1746898

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

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