Home NDC 71162-201-10 Gallium Ga-68 PSMA-11
Product NDC 71162-201
Requested package NDC 71162-201-10
11-digit product format 711620201
Labeler code 71162
Product ID 71162-201_5dabcb44-ec5b-c895-e063-6294a90ae705
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 45 .
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 2026-11-14 07:37:17 2026-10 A219189-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A219189-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 A219189-001 GALLIUM GA 68 GOZETOTIDE 0.5-5mCi/ML SOLUTION / INTRAVENOUS AP 2026-05-14 84e616aacf4f…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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