cetrorelix acetate

Product NDC
65219-292
11-digit product format
652190292
Labeler code
65219
Product ID
65219-292_96fa0188-c4cd-4e23-b376-457bd6df8e2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cetrorelix acetate
Dosage form
KIT
Labeler
FRESENIUS KABI USA, LLC
Application
ANDA218150
Marketing category
ANDA
Marketing start
2024-07-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cetrorelix acetate
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui283402

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52b64100-83c4-4b2c-91ed-8d03f311b48cProduct name420260317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-292-77cetrorelix acetate1 in 1 TRAYKIT11
65219-292-77cetrorelix acetate1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-292-77EA - Each65219-292f323762f-d46e-4995-9c77-8a9460a90f4512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-292CETRORELIX ACETATE KIT [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20240731_c9c50fcb-b28d-4085-9116-b38a21d31b99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283402cetrorelix 0.25 MG InjectionPSNc9c50fcb-b28d-4085-9116-b38a21d31b991
283402cetrorelix 0.25 MG InjectionSCDc9c50fcb-b28d-4085-9116-b38a21d31b991
283402cetrorelix (as cetrorelix acetate) 0.25 MG InjectionSYc9c50fcb-b28d-4085-9116-b38a21d31b991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-292-77652190292771 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01) 1 tray2024-07-31NoNoCurrent