Kit for the Preparation of Technetium Tc 99m Mebrofenin
- Product NDC
- 45567-0455
- 11-digit product format
- 455670455
- Labeler code
- 45567
- Product ID
- 45567-0455_20bf6038-c480-0b7f-e063-6394a90a8d65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Kit for the Preparation of Technetium Tc 99m Mebrofenin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078242
- Marketing category
- ANDA
- Marketing start
- 2008-01-29
- Substance
- MEBROFENIN
- Active strength
- 45 mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kit for the Preparation of Technetium Tc 99m Mebrofenin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEBROFENIN | 45 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7PV0B6ED98 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45567-0455-1 | Kit for the Preparation of Technetium Tc 99m Mebrofenin | 5 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 5 | | 11 |
| 45567-0455-1 | Kit for the Preparation of Technetium Tc 99m Mebrofenin | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 11 |
| 45567-0455-2 | Kit for the Preparation of Technetium Tc 99m Mebrofenin | 30 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 30 | | 11 |
| 45567-0455-2 | Kit for the Preparation of Technetium Tc 99m Mebrofenin | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MEBROFENIN | ACTIVE INGREDIENT | 7PV0B6ED98 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| MEBROFENIN | ACTIVE MOIETY | 7PV0B6ED98 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| STANNOUS FLUORIDE | INACTIVE INGREDIENT | 3FTR44B32Q | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45567-0455 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20240907_11492bd5-2ade-4eb4-a23c-b9be99c0d51a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45567-0455-1 | 45567045501 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0455-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2008-01-29 | 0000-00-00 | No | No | Current |
| 45567-0455-2 | 45567045502 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0455-2) / 10 mL in 1 VIAL, MULTI-DOSE | 2008-01-29 | 0000-00-00 | No | No | Current |