Cetrorelix acetate

Product NDC
60505-6270
11-digit product format
605056270
Labeler code
60505
Product ID
60505-6270_944e22b5-4cab-4aa7-955c-d6bdecb7f716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetrorelix Acetate for Injection
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Apotex Corp.
Application
ANDA217776
Marketing category
ANDA
Marketing start
2024-05-13
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
60505-6270-1Cetrorelix acetate1 in 1 CARTONKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6270-1EA - Each60505-62708cb84554-35fb-41ef-9b87-a68477b2c16512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6270CETRORELIX ACETATE (CETRORELIX ACETATE FOR INJECTION) KIT [APOTEX CORP.]2Current NDC, 1 package rows20240516_95b852d6-26a4-4aaf-a4c3-26340a24723d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283402cetrorelix 0.25 MG InjectionPSN95b852d6-26a4-4aaf-a4c3-26340a24723d3
283402cetrorelix 0.25 MG InjectionSCD95b852d6-26a4-4aaf-a4c3-26340a24723d3
283402cetrorelix (as cetrorelix acetate) 0.25 MG InjectionSY95b852d6-26a4-4aaf-a4c3-26340a24723d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-6270-1605056270011 KIT in 1 CARTON (60505-6270-1) * 1 mL in 1 VIAL, GLASS (60505-6281-0) * 1 mL in 1 SYRINGE, GLASS (60505-6276-0) 1 kit2024-05-13NoNoHistorical