Cetrorelix Acetate

Product NDC
71288-558
11-digit product format
712880558
Labeler code
71288
Product ID
71288-558_1f143808-6446-45a1-9a8c-9e58a26c22cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetrorelix Acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214540
Marketing category
ANDA
Marketing start
2024-04-24
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
71288-558-90Cetrorelix Acetate1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-558-90EA - Each71288-558046f0407-d84f-4951-86f0-e0dc4c40696d12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-558CETRORELIX ACETATE KIT [MEITHEAL PHARMACEUTICALS INC.]7Current NDC, 1 package rows20241212_9b3057ac-6cac-4509-a355-df76247b992c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283402cetrorelix 0.25 MG InjectionPSN9b3057ac-6cac-4509-a355-df76247b992c7
283402cetrorelix 0.25 MG InjectionSCD9b3057ac-6cac-4509-a355-df76247b992c7
283402cetrorelix (as cetrorelix acetate) 0.25 MG InjectionSY9b3057ac-6cac-4509-a355-df76247b992c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-558-90712880558901 KIT in 1 CARTON (71288-558-90) * 2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02) * 1 mL in 1 SYRINGE, GLASS (71288-557-81) 1 kit2024-04-24NoNoCurrent