levothyroxine sodium

Generic: levothyroxine sodium

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
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levothyroxine sodium 100 ug/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-895
Product ID 63323-895_09cdd46f-eae9-4faa-b3b3-67fcd71b62ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210632
Listing Expiration 2026-12-31
Marketing Start 2018-05-29

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323895
Hyphenated Format 63323-895

Supplemental Identifiers

RxCUI
2166148 2166193 2166196
UPC
0363323895105 0363323885106 0363323890100
UNII
9J765S329G

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 (source: ndc)
Application Number NDA210632 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-895-10) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-895-10 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-895-10) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levothyroxine sodium (100 ug/mL)

Linked Drug Pages (1)

Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "09cdd46f-eae9-4faa-b3b3-67fcd71b62ff", "openfda": {"upc": ["0363323895105", "0363323885106", "0363323890100"], "unii": ["9J765S329G"], "rxcui": ["2166148", "2166193", "2166196"], "spl_set_id": ["08f4b1f8-6807-47e7-bef8-8d1972aa0557"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-895-10)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-895-10", "marketing_start_date": "20180529"}], "brand_name": "Levothyroxine Sodium", "product_id": "63323-895_09cdd46f-eae9-4faa-b3b3-67fcd71b62ff", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "63323-895", "generic_name": "Levothyroxine Sodium", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "100 ug/mL"}], "application_number": "NDA210632", "marketing_category": "NDA", "marketing_start_date": "20180529", "listing_expiration_date": "20261231"}