simlandi

Generic: adalimumab-ryvk

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name simlandi
Generic Name adalimumab-ryvk
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 51759-523
Product ID 51759-523_90174eed-a6f4-4153-92a1-623aadbcdc24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761299
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51759523
Hyphenated Format 51759-523

Supplemental Identifiers

RxCUI
797544 2677780 2677787 2688819 2688823 2688826 2688827 2688828 2688829 2706644 2706645

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 simlandi (source: ndc)
Generic Name adalimumab-ryvk (source: ndc)
Application Number BLA761299 (source: ndc)
Routes
subcutaneous
source: label

Resolved Composition

Strengths
  • 80 mg/0.8 ml
  • 40 mg/0.4 ml
  • 20 mg/0.2 ml
  • 1 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (51759-523-21) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31) * .4 mL in 1 POUCH (65517-0002-1)
source: ndc

Packages (1)

51759-523-21 1 KIT in 1 CARTON (51759-523-21) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31) * .4 mL in 1 POUCH (65517-0002-1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Simlandi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "90174eed-a6f4-4153-92a1-623aadbcdc24", "openfda": {"rxcui": ["797544", "2677780", "2677787", "2688819", "2688823", "2688826", "2688827", "2688828", "2688829", "2706644", "2706645"], "spl_set_id": ["12f609c9-2088-bb05-e063-6394a90a9ecc"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (51759-523-21)  / 1 KIT in 1 KIT *  1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (51759-634-31)  *  .4 mL in 1 POUCH (65517-0002-1)", "package_ndc": "51759-523-21", "marketing_start_date": "20250129"}], "brand_name": "Simlandi", "product_id": "51759-523_90174eed-a6f4-4153-92a1-623aadbcdc24", "dosage_form": "KIT", "product_ndc": "51759-523", "generic_name": "adalimumab-ryvk", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Simlandi", "application_number": "BLA761299", "marketing_category": "BLA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}