levothyroxine sodium

Generic: levothyroxine sodium anhydrous

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium anhydrous
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levothyroxine sodium anhydrous 500 ug/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-648
Product ID 63323-648_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202231
Listing Expiration 2026-12-31
Marketing Start 2011-06-24

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323648
Hyphenated Format 63323-648

Supplemental Identifiers

RxCUI
966219 1115267 1115269
UPC
0363323648107 0363323649074 0363323647100
UNII
054I36CPMN

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 levothyroxine sodium (source: ndc)
Generic Name levothyroxine sodium anhydrous (source: ndc)
Application Number NDA202231 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 ug/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-648-10) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-648-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-648-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levothyroxine sodium anhydrous (500 ug/5mL)

Linked Drug Pages (2)

Levothyroxine Sodium ndc-match (0.9) Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea", "openfda": {"upc": ["0363323648107", "0363323649074", "0363323647100"], "unii": ["054I36CPMN"], "rxcui": ["966219", "1115267", "1115269"], "spl_set_id": ["ce990712-49c1-4f66-9ee4-c770e8ec394c"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-648-10)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-648-10", "marketing_start_date": "20110624"}], "brand_name": "Levothyroxine Sodium", "product_id": "63323-648_1da8e5bc-aeb7-4168-a8c3-e1d9a9d167ea", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "63323-648", "generic_name": "LEVOTHYROXINE SODIUM ANHYDROUS", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM ANHYDROUS", "strength": "500 ug/5mL"}], "application_number": "NDA202231", "marketing_category": "NDA", "marketing_start_date": "20110624", "listing_expiration_date": "20261231"}