kelnor 1/35

Generic: ethynodiol diacetate and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name kelnor 1/35
Generic Name ethynodiol diacetate and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9064
Product ID 0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076785
Listing Expiration 2026-12-31
Marketing Start 2005-06-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05559064
Hyphenated Format 0555-9064

Supplemental Identifiers

RxCUI
310228 748797 748804 753483

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 kelnor 1/35 (source: ndc)
Generic Name ethynodiol diacetate and ethinyl estradiol (source: ndc)
Application Number ANDA076785 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 0.035 mg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9064-58 6 POUCH in 1 CARTON (0555-9064-58) / 1 BLISTER PACK in 1 POUCH (0555-9064-79) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Kelnor 1/35 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3", "openfda": {"rxcui": ["310228", "748797", "748804", "753483"], "spl_set_id": ["96a73786-22b1-457e-be73-80b699996d40"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0555-9064-58)  / 1 BLISTER PACK in 1 POUCH (0555-9064-79)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9064-58", "marketing_start_date": "20050620"}], "brand_name": "Kelnor 1/35", "product_id": "0555-9064_a579e715-cf4d-4d28-9bb7-3b4e2d4dc4d3", "dosage_form": "KIT", "product_ndc": "0555-9064", "generic_name": "Ethynodiol Diacetate and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kelnor 1/35", "application_number": "ANDA076785", "marketing_category": "ANDA", "marketing_start_date": "20050620", "listing_expiration_date": "20261231"}