levothyroxine sodium

Generic: levothyroxine sodium

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levothyroxine sodium .112 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1835
Product ID 69238-1835_3a92e520-3da8-43be-9be2-63511c44b735
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021210
Listing Expiration 2026-12-31
Marketing Start 2003-12-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381835
Hyphenated Format 69238-1835

Supplemental Identifiers

RxCUI
892246 892251 892255 966220 966221 966222 966224 966225 966248 966249 966253 966270
UPC
0369238184112 0369238183719 0369838123016
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 NDA021210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .112 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (69238-1835-1)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (69238-1835-7)
source: ndc

Packages (2)

69238-1835-1 100 TABLET in 1 BOTTLE, PLASTIC (69238-1835-1) 69238-1835-7 1000 TABLET in 1 BOTTLE, PLASTIC (69238-1835-7)

Ingredients (1)

levothyroxine sodium (.112 mg/1)

Linked Drug Pages (1)

Levothyroxine Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a92e520-3da8-43be-9be2-63511c44b735", "openfda": {"upc": ["0369238184112", "0369238183719", "0369838123016"], "unii": ["9J765S329G"], "rxcui": ["892246", "892251", "892255", "966220", "966221", "966222", "966224", "966225", "966248", "966249", "966253", "966270"], "spl_set_id": ["fca88c97-5cd4-4834-ba87-deb5bd637788"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69238-1835-1)", "package_ndc": "69238-1835-1", "marketing_start_date": "20031201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (69238-1835-7)", "package_ndc": "69238-1835-7", "marketing_start_date": "20031201"}], "brand_name": "Levothyroxine Sodium", "product_id": "69238-1835_3a92e520-3da8-43be-9be2-63511c44b735", "dosage_form": "TABLET", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "69238-1835", "generic_name": "Levothyroxine Sodium", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": ".112 mg/1"}], "application_number": "NDA021210", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20031201", "listing_expiration_date": "20261231"}