Glofil-125
- Product NDC
- 50914-7729
- 11-digit product format
- 509147729
- Labeler code
- 50914
- Product ID
- 50914-7729_03a98b4c-213b-4537-8d3a-aaa9f9f1cc9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Iothalamate I-125 injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Iso-Tex Diagnostics, Inc.
- Application
- NDA017279
- Marketing category
- NDA
- Marketing start
- 1983-05-01
- Substance
- IOTHALAMATE SODIUM I-125
- Active strength
- .275 mCi/mL
- 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
- Glofil-125
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOTHALAMATE SODIUM I-125 | .275 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 31J5U3Q9ZN |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50914-7729-2 | Glofil-125 | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 4 |
| 50914-7729-2 | Glofil-125 | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 4 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IOTHALAMATE SODIUM I-125 | ACTIVE INGREDIENT | 31J5U3Q9ZN | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 2 | |
| IOTHALAMIC ACID I-125 | ACTIVE MOIETY | 2XLB86RCW8 | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 2 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50914-7729 | GLOFIL-125 (SODIUM IOTHALAMATE I-125 INJECTION) INJECTION, SOLUTION [ISO-TEX DIAGNOSTICS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20191218_7f250086-2837-484b-9674-e09856b34cb0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50914-7729-2 | 50914772902 | 1 VIAL, MULTI-DOSE in 1 BOX (50914-7729-2) / 4 mL in 1 VIAL, MULTI-DOSE | 1983-05-01 | 0000-00-00 | No | No | Current |