Cetrorelix acetate

Product NDC
67184-0605
11-digit product format
671840605
Labeler code
67184
Product ID
67184-0605_60fea8d3-ccd9-4714-80c5-b8f178f34ca3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetrorelix Acetate for Injection
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Qilu Pharmaceutical Co., Ltd.
Application
ANDA217776
Marketing category
ANDA
Marketing start
2024-04-16
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
67184-0605-2Cetrorelix acetate1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0605CETRORELIX ACETATE (CETRORELIX ACETATE FOR INJECTION) KIT [QILU PHARMACEUTICAL CO., LTD.]1Current NDC, 1 package rows20240420_c1f35ca4-3536-44ca-ad0e-02f484019456.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283402cetrorelix 0.25 MG InjectionPSNc1f35ca4-3536-44ca-ad0e-02f4840194561
283402cetrorelix 0.25 MG InjectionSCDc1f35ca4-3536-44ca-ad0e-02f4840194561
283402cetrorelix (as cetrorelix acetate) 0.25 MG InjectionSYc1f35ca4-3536-44ca-ad0e-02f4840194561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67184-0605-2671840605021 KIT in 1 CARTON (67184-0605-2) * 1 mL in 1 VIAL, GLASS (67184-0567-1) * 1 mL in 1 SYRINGE, GLASS (67184-0568-1) 1 kit2024-04-16NoNoHistorical