ermeza

Generic: levothyroxine sodium

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ermeza
Generic Name levothyroxine sodium
Labeler viatris specialty llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

levothyroxine sodium 30 ug/mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-378
Product ID 49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215809
Marketing Start 2022-12-14
Marketing End 2026-07-31

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502378
Hyphenated Format 49502-378

Supplemental Identifiers

RxCUI
2626050 2626056
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 ermeza (source: ndc)
Generic Name levothyroxine sodium (source: ndc)
Application Number NDA215809 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 ug/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS
  • 1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS
source: ndc

Packages (2)

49502-378-15 1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS 49502-378-75 1 BOTTLE, GLASS in 1 CARTON (49502-378-75) / 75 mL in 1 BOTTLE, GLASS

Ingredients (1)

levothyroxine sodium (30 ug/mL)

Linked Drug Pages (1)

ERMEZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c", "openfda": {"unii": ["9J765S329G"], "rxcui": ["2626050", "2626056"], "spl_set_id": ["8ceeadb4-18be-46c7-9204-68b4edfbb96b"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (49502-378-15)  / 150 mL in 1 BOTTLE, GLASS", "package_ndc": "49502-378-15", "marketing_end_date": "20260731", "marketing_start_date": "20221214"}, {"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (49502-378-75)  / 75 mL in 1 BOTTLE, GLASS", "package_ndc": "49502-378-75", "marketing_end_date": "20260731", "marketing_start_date": "20221214"}], "brand_name": "ERMEZA", "product_id": "49502-378_97c0bb6f-0f8d-414d-88eb-a1590aeaeb9c", "dosage_form": "SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "49502-378", "generic_name": "levothyroxine sodium", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERMEZA", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "30 ug/mL"}], "application_number": "NDA215809", "marketing_category": "NDA", "marketing_end_date": "20260731", "marketing_start_date": "20221214"}