nortrel 7/7/7 (28 day regimen)

Generic: norethindrone and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name nortrel 7/7/7 (28 day regimen)
Generic Name norethindrone and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9012
Product ID 0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075478
Listing Expiration 2027-12-31
Marketing Start 2003-01-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05559012
Hyphenated Format 0555-9012

Supplemental Identifiers

RxCUI
310463 312033 392662 748797 749852 762007

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 nortrel 7/7/7 (28 day regimen) (source: ndc)
Generic Name norethindrone and ethinyl estradiol (source: ndc)
Application Number ANDA075478 (source: ndc)

Resolved Composition

Strengths
  • 0.035 mg
  • 0.5 mg
  • 0.75 mg
  • 1 mg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9012-58 6 POUCH in 1 CARTON (0555-9012-58) / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Nortrel 7/7/7 (28 Day Regimen) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "5157d13b-a384-46cb-9e9e-f3691d4f9072", "openfda": {"rxcui": ["310463", "312033", "392662", "748797", "749852", "762007"], "spl_set_id": ["992dcc56-90ab-4691-8114-16d47a8b9982"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0555-9012-58)  / 1 BLISTER PACK in 1 POUCH (0555-9012-79)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9012-58", "marketing_start_date": "20030102"}], "brand_name": "Nortrel 7/7/7 (28 Day Regimen)", "product_id": "0555-9012_5157d13b-a384-46cb-9e9e-f3691d4f9072", "dosage_form": "KIT", "product_ndc": "0555-9012", "generic_name": "Norethindrone and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortrel 7/7/7", "brand_name_suffix": "(28 Day Regimen)", "application_number": "ANDA075478", "marketing_category": "ANDA", "marketing_start_date": "20030102", "listing_expiration_date": "20271231"}