Gallium Ga-68 PSMA-11
- Product NDC
- 24275-0525
- 11-digit product format
- 242750525
- Labeler code
- 24275
- Product ID
- 24275-0525_4395a8f3-f489-e90c-e063-6294a90a7ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GALLIUM GA-68 GOZETOTIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- UCSF Radiopharmaceutical Facility
- Application
- NDA212643
- Marketing category
- NDA
- Marketing start
- 2020-12-14
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gallium Ga-68 PSMA-11
- Listing expiration
- 2026-12-31
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 |
|---|
| 24275-0525-1 | Gallium Ga-68 PSMA-11 | 11 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 11 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24275-0525 | GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCSF RADIOPHARMACEUTICAL FACILITY] | 7 | Current NDC, Legacy NDC, 1 package rows | 20241013_b6253a7b-0f73-36be-e053-2a95a90a9015.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24275-0525-1 | 24275052501 | 11 mL in 1 VIAL, MULTI-DOSE (24275-0525-1) | 11 ml | 2020-12-14 | 0000-00-00 | No | No | Current |