Home NDC 65857-500-20 Kit for the Preparation of Technetium Tc99m Sestamibi
Product NDC 65857-500
Requested package NDC 65857-500-20
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078809-001 TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE / INJECTION AP 2009-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078809-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A078809-001 TECHNETIUM TC 99M SESTAMIBI N/A INJECTABLE / INJECTION AP 2009-04-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078809-001 AP 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 65857-500-20 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