Home NDC 71162-201 Gallium Ga-68 PSMA-11
Product NDC 71162-201
11-digit product format 711620201
Labeler code 71162
Product ID 71162-201_51ca091b-2dd4-d547-e063-6394a90a4fb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GALLIUM GA-68 GOZETOTIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Ionetix Corporation
Application ANDA219189
Marketing category ANDA
Marketing start 2024-01-17
Substance GALLIUM GA-68 GOZETOTIDE
Active strength 5 mCi/mL
Pharmacologic classes Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219189-001 GALLIUM GA 68 GOZETOTIDE GALLIUM GA-68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219189-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A219189-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219189-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219189-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219189-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Gallium Ga-68 PSMA-11
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GALLIUM GA-68 GOZETOTIDE 5 mCi/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ZJ0EKR6M10 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71162-201-10 Gallium Ga-68 PSMA-11 9 mL in 1 SYRINGE INJECTION, SOLUTION 9 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71162-201-10 71162020110 9 mL in 1 SYRINGE (71162-201-10) 9 ml 2024-01-17 No No Current