Megatope
- Product NDC
- 50914-7731
- 11-digit product format
- 509147731
- Labeler code
- 50914
- Product ID
- 50914-7731_a0a63fb3-6957-4446-8bf0-67c91325f753
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iodinated I-131 Albumin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Iso-Tex Diagnostics, Inc.
- Application
- BLA017837
- Marketing category
- BLA
- Marketing start
- 1996-05-21
- Substance
- HUMAN SERUM ALBUMIN I-131
- Active strength
- 1 mCi/mL
- Pharmacologic classes
- 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
- Megatope
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN SERUM ALBUMIN I-131 | 1 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ACH35131L1 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50914-7731-4 | Megatope | 8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 8 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IODINATED I-131 SERUM ALBUMIN | ACTIVE INGREDIENT | ACH35131L1 | MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 1 | |
| IODINATED I-131 SERUM ALBUMIN | ACTIVE MOIETY | ACH35131L1 | MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 1 | |
| ALBUMIN HUMAN | INACTIVE INGREDIENT | ZIF514RVZR | MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50914-7731 | MEGATOPE (IODINATED I-131 ALBUMIN ) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230908_62ca4278-8cc9-46b7-8f3c-303ce6a9c155.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50914-7731-4 | 50914773104 | 8 mL in 1 VIAL, MULTI-DOSE (50914-7731-4) | 8 ml | 1996-05-21 | 0000-00-00 | No | No | Current |