balziva

Generic: norethindrone and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name balziva
Generic Name norethindrone and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9034
Product ID 0555-9034_7885d65c-3e23-4a03-9d1b-132893517c04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076238
Listing Expiration 2026-12-31
Marketing Start 2006-10-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05559034
Hyphenated Format 0555-9034

Supplemental Identifiers

RxCUI
238015 748797 749736 1095362

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 balziva (source: ndc)
Generic Name norethindrone and ethinyl estradiol (source: ndc)
Application Number ANDA076238 (source: ndc)

Resolved Composition

Strengths
  • 0.4 mg
  • 0.035 mg
  • 1 %
  • 3 %
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9034-58) / 1 BLISTER PACK in 1 POUCH (0555-9034-79) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9034-58 6 POUCH in 1 CARTON (0555-9034-58) / 1 BLISTER PACK in 1 POUCH (0555-9034-79) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Balziva ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "7885d65c-3e23-4a03-9d1b-132893517c04", "openfda": {"rxcui": ["238015", "748797", "749736", "1095362"], "spl_set_id": ["36a282d2-7285-442b-9574-dfce2d9456f1"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0555-9034-58)  / 1 BLISTER PACK in 1 POUCH (0555-9034-79)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9034-58", "marketing_start_date": "20061016"}], "brand_name": "Balziva", "product_id": "0555-9034_7885d65c-3e23-4a03-9d1b-132893517c04", "dosage_form": "KIT", "product_ndc": "0555-9034", "generic_name": "Norethindrone and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Balziva", "application_number": "ANDA076238", "marketing_category": "ANDA", "marketing_start_date": "20061016", "listing_expiration_date": "20261231"}