levothyroxine sodium

Generic: levothyroxine sodium

Labeler: yaral pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name levothyroxine sodium
Generic Name levothyroxine sodium
Labeler yaral pharma inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

levothyroxine sodium 25 ug/1

Manufacturer
YARAL Pharma Inc.

Identifiers & Regulatory

Product NDC 82347-0010
Product ID 82347-0010_47a78ab3-8c9e-3fcd-e063-6294a90a2c1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021924
Listing Expiration 2027-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Classes
thyroxine [cs] l-thyroxine [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 823470010
Hyphenated Format 82347-0010

Supplemental Identifiers

RxCUI
905451 905455 905458 905462 966404 966405 966406 966407 966412 966413 1923047 1923050
UPC
0382347003044 0382347005048 0382347003549 0382347001545 0382347000548 0382347004546 0382347002047 0382347006045 0382347002542 0382347001040 0382347004041 0382347005543
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 NDA021924 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 ug/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (82347-0010-4) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

82347-0010-4 3 BLISTER PACK in 1 CARTON (82347-0010-4) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (1)

levothyroxine sodium (25 ug/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": "47a78ab3-8c9e-3fcd-e063-6294a90a2c1f", "openfda": {"upc": ["0382347003044", "0382347005048", "0382347003549", "0382347001545", "0382347000548", "0382347004546", "0382347002047", "0382347006045", "0382347002542", "0382347001040", "0382347004041", "0382347005543"], "unii": ["9J765S329G"], "rxcui": ["905451", "905455", "905458", "905462", "966404", "966405", "966406", "966407", "966412", "966413", "1923047", "1923050"], "spl_set_id": ["d28d7202-1278-0486-e053-2995a90af286"], "manufacturer_name": ["YARAL Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (82347-0010-4)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "82347-0010-4", "marketing_start_date": "20230301"}], "brand_name": "Levothyroxine Sodium", "product_id": "82347-0010_47a78ab3-8c9e-3fcd-e063-6294a90a2c1f", "dosage_form": "CAPSULE", "pharm_class": ["Thyroxine [CS]", "l-Thyroxine [EPC]"], "product_ndc": "82347-0010", "generic_name": "levothyroxine sodium", "labeler_name": "YARAL Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Levothyroxine Sodium", "active_ingredients": [{"name": "LEVOTHYROXINE SODIUM", "strength": "25 ug/1"}], "application_number": "NDA021924", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230301", "listing_expiration_date": "20271231"}