levothyroxine sodium

Generic: levothyroxine sodium

Labeler: piramal critical care, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler piramal critical care, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

levothyroxine sodium anhydrous 100 ug/5mL

Manufacturer
Piramal Critical Care, Inc.

Identifiers & Regulatory

Product NDC 66794-200
Product ID 66794-200_3f9e1bbc-d3e2-c795-e063-6394a90aecdf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206163
Listing Expiration 2026-12-31
Marketing Start 2022-10-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66794200
Hyphenated Format 66794-200

Supplemental Identifiers

RxCUI
966219 1115267
UPC
0366794200027 0366794201024
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 (source: ndc)
Application Number ANDA206163 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/5mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, SINGLE-USE (66794-200-02)
source: ndc

Packages (1)

66794-200-02 5 mL in 1 VIAL, SINGLE-USE (66794-200-02)

Ingredients (1)

levothyroxine sodium anhydrous (100 ug/5mL)

Linked Drug Pages (1)

Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3f9e1bbc-d3e2-c795-e063-6394a90aecdf", "openfda": {"upc": ["0366794200027", "0366794201024"], "unii": ["054I36CPMN"], "rxcui": ["966219", "1115267"], "spl_set_id": ["76139990-1355-cfb6-e053-2991aa0ace5b"], "manufacturer_name": ["Piramal Critical Care, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, SINGLE-USE (66794-200-02)", "package_ndc": "66794-200-02", "marketing_start_date": "20221001"}], "brand_name": "Levothyroxine Sodium", "product_id": "66794-200_3f9e1bbc-d3e2-c795-e063-6394a90aecdf", "dosage_form": "INJECTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "66794-200", "generic_name": "Levothyroxine Sodium", "labeler_name": "Piramal Critical Care, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM ANHYDROUS", "strength": "100 ug/5mL"}], "application_number": "ANDA206163", "marketing_category": "ANDA", "marketing_start_date": "20221001", "listing_expiration_date": "20261231"}