Gallium Ga-68 PSMA-11
- Product NDC
- 76394-2642
- 11-digit product format
- 763942642
- Labeler code
- 76394
- Product ID
- 76394-2642_2784e7a8-d4f1-fa61-e063-6394a90a614e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GALLIUM GA-68 GOZETOTIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- UCLA Biomedical Cyclotron
- Application
- NDA212642
- Marketing category
- NDA
- Marketing start
- 2020-12-09
- 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 |
|---|
| 76394-2642-3 | Gallium Ga-68 PSMA-11 | 12 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 12 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76394-2642 | GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCLA BIOMEDICAL CYCLOTRON] | 6 | Current NDC, Legacy NDC, 1 package rows | 20241123_7744bafb-755e-29a2-e053-2991aa0a86a9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76394-2642-3 | 76394264203 | 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3) | 12 ml | 2020-12-09 | 0000-00-00 | No | No | Current |