LOCAMETZ

Product NDC
0078-1224
11-digit product format
000781224
Labeler code
0078
Product ID
0078-1224_8683b06e-4901-4526-89ad-23a8fe2d1331
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
Novartis Pharmaceuticals Corporation
Application
NDA215841
Marketing category
NDA
Marketing start
2022-03-23
Substance
GOZETOTIDE
Active strength
25 ug/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LOCAMETZ
Listing expiration
2027-12-31

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-1224-61LOCAMETZ1 in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,11
0078-1224-61LOCAMETZ1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-1224-61EA - Each0078-1224488e9f6f-c013-4924-b5ef-451f5536ab4c12026-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0078-1224-61000781224611 VIAL, MULTI-DOSE in 1 CARTON (0078-1224-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE2026-01-15NoNoCurrent