FDA.reportPublic FDA data

Cetrotide

Product NDC
44087-1225
11-digit product format
440871225
Labeler code
44087
Product ID
44087-1225_716029d9-4462-4732-846c-456e74363b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cetrorelix acetate
Dosage form
KIT
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
NDA021197
Marketing category
NDA
Marketing start
2000-08-11
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui283402, 284441

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-1225-12022-02-04C16284748780-1d6a99b39-ea4d-a426-e053-dadaa90af4c2Cetrotide ® 0.25 mg (cetrorelix acetate for injection)
44087-1225-12022-01-28C16284748780-1d6a99b39-ea4d-a426-e053-dadaa90af4c2Cetrotide ® 0.25 mg (cetrorelix acetate for injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-1225-1Cetrotide1 in 1 CARTONKIT118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-1225-1EA - Each44087-12255f3f88d2-fa66-4efa-8153-3627a1383b4912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETRORELIX ACETATEACTIVE INGREDIENTW9Y8L7GP4CCETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]6
CETRORELIXACTIVE MOIETYOON1HFZ4BACETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ACETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RCETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-1225CETROTIDE (CETRORELIX ACETATE) KIT [EMD SERONO, INC.]17Current NDC, Legacy NDC, 1 package rows20240619_aca7768e-28a7-4027-b1d8-e66247665f79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283402cetrorelix 0.25 MG InjectionPSNaca7768e-28a7-4027-b1d8-e66247665f7918
284441Cetrotide 0.25 MG InjectionPSNaca7768e-28a7-4027-b1d8-e66247665f7918
284441cetrorelix 0.25 MG Injection [Cetrotide]SBDaca7768e-28a7-4027-b1d8-e66247665f7918
283402cetrorelix 0.25 MG InjectionSCDaca7768e-28a7-4027-b1d8-e66247665f7918
283402cetrorelix (as cetrorelix acetate) 0.25 MG InjectionSYaca7768e-28a7-4027-b1d8-e66247665f7918
284441Cetrotide 0.25 MG InjectionSYaca7768e-28a7-4027-b1d8-e66247665f7918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-1225-1440871225011 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS1 kit2000-08-110000-00-00NoNoCurrent