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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZJ0EKR6M10 |
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 |