RUBY-FILL
- Product NDC
- 65174-021
- 11-digit product format
- 651740021
- Labeler code
- 65174
- Product ID
- 65174-021_efb00947-c7d1-4fc8-8ca0-24d80952b7ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rubidium Rb 82
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Application
- NDA202153
- Marketing category
- NDA
- Marketing start
- 2016-09-30
- Substance
- RUBIDIUM CHLORIDE RB-82
- Active strength
- 100 mCi/1
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RUBY-FILL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RUBIDIUM CHLORIDE RB-82 | 100 mCi/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F0Z746KRKQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65174-021-10 | RUBY-FILL | 1 in 1 CONTAINER | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65174-021 | RUBY-FILL (RUBIDIUM RB 82) INJECTION, SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] | 8 | Current NDC, Legacy NDC, 1 package rows | 20201201_b3c0cc0c-2f4b-4e08-8a84-3cb77473c2e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65174-021-10 | 65174002110 | 1 INJECTION, SOLUTION in 1 CONTAINER (65174-021-10) | 2016-09-30 | 0000-00-00 | No | No | Current |