tyblume

Generic: levonorgestrel and ethinyl estradiol

Labeler: exeltis usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tyblume
Generic Name levonorgestrel and ethinyl estradiol
Labeler exeltis usa, inc.
Dosage Form KIT
Manufacturer
Exeltis USA, Inc.

Identifiers & Regulatory

Product NDC 0642-7471
Product ID 0642-7471_f48a4726-8731-6fcb-e053-2995a90a6bea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209405
Listing Expiration 2026-12-31
Marketing Start 2020-10-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06427471
Hyphenated Format 0642-7471

Supplemental Identifiers

RxCUI
242297 2465331 2539224 2539227 2539228

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 tyblume (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number NDA209405 (source: ndc)

Resolved Composition

Strengths
  • 0.1 mg
  • 0.02 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

0642-7471-01 1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACK 0642-7471-02 1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Tyblume ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "f48a4726-8731-6fcb-e053-2995a90a6bea", "openfda": {"rxcui": ["242297", "2465331", "2539224", "2539227", "2539228"], "spl_set_id": ["b2482d51-d606-4aaa-8af4-19e4fe2f8872"], "manufacturer_name": ["Exeltis USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX (0642-7471-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0642-7471-01", "marketing_start_date": "20201026"}, {"sample": true, "description": "1 BLISTER PACK in 1 BOX (0642-7471-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0642-7471-02", "marketing_start_date": "20201026"}], "brand_name": "Tyblume", "product_id": "0642-7471_f48a4726-8731-6fcb-e053-2995a90a6bea", "dosage_form": "KIT", "product_ndc": "0642-7471", "generic_name": "Levonorgestrel and Ethinyl Estradiol", "labeler_name": "Exeltis USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tyblume", "application_number": "NDA209405", "marketing_category": "NDA", "marketing_start_date": "20201026", "listing_expiration_date": "20261231"}