Kit for the Preparation of Technetium Tc99m Sestamibi
- Product NDC
- 65857-500
- 11-digit product format
- 658570500
- Labeler code
- 65857
- Product ID
- 65857-500_a5589464-e5bb-47b5-8a0c-372df1d7aed5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Kit for the Preparation of Technetium Tc99m Sestamibi
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- PARENTERAL
- Labeler
- Cardinal Health 414, LLC
- Application
- ANDA078809
- Marketing category
- ANDA
- Marketing start
- 2010-06-01
- Substance
- TECHNETIUM TC-99M SESTAMIBI
- Active strength
- 1 mg/5mL
- 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 Tc99m Sestamibi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TECHNETIUM TC-99M SESTAMIBI | 1 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 971Z4W1S09 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65857-500-05 | Kit for the Preparation of Technetium Tc99m Sestamibi | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 9 |
| 65857-500-05 | Kit for the Preparation of Technetium Tc99m Sestamibi | 5 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 5 | | 9 |
| 65857-500-20 | Kit for the Preparation of Technetium Tc99m Sestamibi | 20 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 20 | | 9 |
| 65857-500-20 | Kit for the Preparation of Technetium Tc99m Sestamibi | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TECHNETIUM TC-99M SESTAMIBI | ACTIVE INGREDIENT | 971Z4W1S09 | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
| TECHNETIUM TC-99M SESTAMIBI | ACTIVE MOIETY | 971Z4W1S09 | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
| CYSTEINE HYDROCHLORIDE | INACTIVE INGREDIENT | ZT934N0X4W | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
| STANNOUS CHLORIDE | INACTIVE INGREDIENT | 1BQV3749L5 | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65857-500 | KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20220726_8626e756-767a-4a14-9188-658b58185254.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65857-500-05 | 65857050005 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 65857-500-20 | 65857050020 | 20 VIAL in 1 CARTON (65857-500-20) / 5 mL in 1 VIAL | 20 vial | 2010-06-01 | 0000-00-00 | No | No | Current |