Kit for the Preparation of Technetium Tc 99M Medronate
- Product NDC
- 45567-0040
- 11-digit product format
- 455670040
- Labeler code
- 45567
- Product ID
- 45567-0040_3010d5a9-2402-c30a-e063-6394a90a73ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TC 99M MEDRONATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA018124
- Marketing category
- NDA
- Marketing start
- 1979-08-29
- Substance
- TECHNETIUM TC-99M MEDRONATE
- Active strength
- 20 mg/10mL
- 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
- Kit for the Preparation of Technetium Tc 99M Medronate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TECHNETIUM TC-99M MEDRONATE | 20 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X89XV46R07 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45567-0040-1 | Kit for the Preparation of Technetium Tc 99M Medronate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 10 | | 11 |
| 45567-0040-1 | Kit for the Preparation of Technetium Tc 99M Medronate | 5 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 5 | | 11 |
| 45567-0040-2 | Kit for the Preparation of Technetium Tc 99M Medronate | 30 in 1 KIT | INJECTION, POWDER, LYOPHILIZED, | 30 | | 11 |
| 45567-0040-2 | Kit for the Preparation of Technetium Tc 99M Medronate | 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 |
|---|
| TECHNETIUM TC-99M MEDRONATE | ACTIVE INGREDIENT | X89XV46R07 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| TECHNETIUM TC-99M MEDRONATE | ACTIVE MOIETY | X89XV46R07 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMALUCENCE, INC.] | 3 | |
| STANNOUS FLUORIDE | INACTIVE INGREDIENT | 3FTR44B32Q | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) 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 |
|---|
| 45567-0040 | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250412_703d347c-e240-408a-b69d-9713e958a201.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45567-0040-1 | 45567004001 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE | 1979-08-29 | 0000-00-00 | No | No | Current |
| 45567-0040-2 | 45567004002 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE | 1979-08-29 | 0000-00-00 | No | No | Current |