kit for the preparation of indium in 111 pentetreotide

Generic: indium in-111 pentetreotide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name kit for the preparation of indium in 111 pentetreotide
Generic Name indium in-111 pentetreotide
Labeler sun pharmaceutical industries, inc.
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 45567-0755
Product ID 45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212785
Listing Expiration 2026-12-31
Marketing Start 2025-03-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 455670755
Hyphenated Format 45567-0755

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kit for the preparation of indium in 111 pentetreotide (source: ndc)
Generic Name indium in-111 pentetreotide (source: ndc)
Application Number ANDA212785 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mcg
  • 2 mg
  • 4.9 mg
  • 0.37 mg
  • 10 mg
  • 1.1 ml
  • 3.5 mcg/ml
  • 1.2 mcg/ml
  • 23 g
source: label
Packaging
  • 1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1)
source: ndc

Packages (1)

45567-0755-3 1 KIT in 1 KIT (45567-0755-3) * 1 mL in 1 VIAL (45567-0752-1) * 1 mL in 1 VIAL (45567-0753-1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Kit for the Preparation of Indium In 111 Pentetreotide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "334fde6d-c2c2-0054-e063-6394a90a26f0", "openfda": {"spl_set_id": ["e2117bbd-9db3-4d20-a5da-89551c18a0cb"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (45567-0755-3)  *  1 mL in 1 VIAL (45567-0752-1)  *  1 mL in 1 VIAL (45567-0753-1)", "package_ndc": "45567-0755-3", "marketing_start_date": "20250325"}], "brand_name": "Kit for the Preparation of Indium In 111 Pentetreotide", "product_id": "45567-0755_334fde6d-c2c2-0054-e063-6394a90a26f0", "dosage_form": "KIT", "product_ndc": "45567-0755", "generic_name": "Indium In-111 Pentetreotide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kit for the Preparation of Indium In 111 Pentetreotide", "application_number": "ANDA212785", "marketing_category": "ANDA", "marketing_start_date": "20250325", "listing_expiration_date": "20261231"}