levothyroxine sodium

Generic: levothyroxine sodium

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

levothyroxine sodium anhydrous 500 ug/5mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1835
Product ID 70710-1835_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217066
Listing Expiration 2026-12-31
Marketing Start 2024-11-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101835
Hyphenated Format 70710-1835

Supplemental Identifiers

RxCUI
966219 1115267 1115269
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 ANDA217066 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 ug/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1835-1) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

70710-1835-1 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1835-1) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

levothyroxine sodium anhydrous (500 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": "2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e", "openfda": {"unii": ["054I36CPMN"], "rxcui": ["966219", "1115267", "1115269"], "spl_set_id": ["bf8a952c-f05b-4814-b55a-ed04be015269"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1835-1)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "70710-1835-1", "marketing_start_date": "20241101"}], "brand_name": "LEVOTHYROXINE SODIUM", "product_id": "70710-1835_2ef84f1a-cf9a-4e93-8b2b-08bf75befd9e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "70710-1835", "generic_name": "levothyroxine sodium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEVOTHYROXINE SODIUM", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM ANHYDROUS", "strength": "500 ug/5mL"}], "application_number": "ANDA217066", "marketing_category": "ANDA", "marketing_start_date": "20241101", "listing_expiration_date": "20261231"}