levothyroxine sodium

Generic: levothyroxine sodium anhydrous

Labeler: maia pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

levothyroxine sodium anhydrous 100 ug/5mL

Manufacturer
MAIA Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70511-111
Product ID 70511-111_9efa2867-7721-478a-a1c3-e34eeb3a1937
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208749
Listing Expiration 2026-12-31
Marketing Start 2018-12-27

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70511111
Hyphenated Format 70511-111

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 anhydrous (source: ndc)
Application Number ANDA208749 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (70511-111-10) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

70511-111-10 1 VIAL, SINGLE-USE in 1 CARTON (70511-111-10) / 5 mL in 1 VIAL, SINGLE-USE

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": "9efa2867-7721-478a-a1c3-e34eeb3a1937", "openfda": {"unii": ["054I36CPMN"], "rxcui": ["966219", "1115267", "1115269"], "spl_set_id": ["4e9adc35-3aba-4a0d-9c4e-7e7ee2ffdabd"], "manufacturer_name": ["MAIA Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (70511-111-10)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "70511-111-10", "marketing_start_date": "20191227"}], "brand_name": "Levothyroxine Sodium", "product_id": "70511-111_9efa2867-7721-478a-a1c3-e34eeb3a1937", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "70511-111", "generic_name": "LEVOTHYROXINE SODIUM ANHYDROUS", "labeler_name": "MAIA Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM ANHYDROUS", "strength": "100 ug/5mL"}], "application_number": "ANDA208749", "marketing_category": "ANDA", "marketing_start_date": "20181227", "listing_expiration_date": "20261231"}