FDA.reportPublic FDA data

LOCAMETZ

Product NDC
69488-017
11-digit product format
694880017
Labeler code
69488
Product ID
69488-017_439c14c1-9d46-428a-ad3b-4e16508c50e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
kit for the preparation of gallium Ga 68 gozetotide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Advanced Accelerator Applications USA, Inc
Application
NDA215841
Marketing category
NDA
Marketing start
2022-03-23
Substance
GOZETOTIDE
Active strength
25 ug/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOZETOTIDE25 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9AG41L3AOQ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
992a1833-9957-43c6-9b91-c0feb8613f61Product name120260107
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69488-017-61LOCAMETZ1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
69488-017-61LOCAMETZ1 in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69488-017-61EA - Each69488-017003ebd2f-d6b5-4779-956e-635c55ff65c612022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69488-017LOCAMETZ (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ADVANCED ACCELERATOR APPLICATIONS USA, INC]7Current NDC, Legacy NDC, 2 package rows20250406_1ea62b65-8138-4a88-8a33-4060ececa42f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69488-017-61694880017611 VIAL, MULTI-DOSE in 1 CARTON (69488-017-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE2022-03-230000-00-00NoNoCurrent