netspot

Generic: 68ga-dotatate

Labeler: advanced accelerator applications usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name netspot
Generic Name 68ga-dotatate
Labeler advanced accelerator applications usa, inc
Dosage Form KIT
Routes
INTRAVENOUS
Manufacturer
Advanced Accelerator Applications USA, Inc

Identifiers & Regulatory

Product NDC 69488-001
Product ID 69488-001_3a8e7db3-9df3-4957-809d-e194516874c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208547
Listing Expiration 2027-12-31
Marketing Start 2016-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69488001
Hyphenated Format 69488-001

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 netspot (source: ndc)
Generic Name 68ga-dotatate (source: ndc)
Application Number NDA208547 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mcg
  • 5 mcg
  • 6 mcg
  • 20 mg
  • 10 ml
  • 60 mg
  • 56.5 mg
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

69488-001-40 1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

NETSPOT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3a8e7db3-9df3-4957-809d-e194516874c0", "openfda": {"spl_set_id": ["b2b3be70-17d8-4093-896c-f1c54a2cf242"], "manufacturer_name": ["Advanced Accelerator Applications USA, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 KIT (69488-001-40)  *  1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "69488-001-40", "marketing_start_date": "20160601"}], "brand_name": "NETSPOT", "product_id": "69488-001_3a8e7db3-9df3-4957-809d-e194516874c0", "dosage_form": "KIT", "product_ndc": "69488-001", "generic_name": "68Ga-DOTATATE", "labeler_name": "Advanced Accelerator Applications USA, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NETSPOT", "application_number": "NDA208547", "marketing_category": "NDA", "marketing_start_date": "20160601", "listing_expiration_date": "20271231"}