norethindrone acetate and ethinyl estradiol

Generic: norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol
Generic Name norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets
Labeler xiromed, llc
Dosage Form KIT
Routes
ORAL
Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-101
Product ID 70700-101_0b7a2fac-2281-4c64-29aa-5e0d05d49236
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209609
Listing Expiration 2026-12-31
Marketing Start 2018-08-24

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700101
Hyphenated Format 70700-101

Supplemental Identifiers

RxCUI
259176 1426288 1426600

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 norethindrone acetate and ethinyl estradiol (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets (source: ndc)
Application Number ANDA209609 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/20 mcg
  • 1 mg
  • 20 mcg
  • 75 mg
source: label
Packaging
  • 3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

70700-101-85 3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Norethindrone Acetate and Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0b7a2fac-2281-4c64-29aa-5e0d05d49236", "openfda": {"rxcui": ["259176", "1426288", "1426600"], "spl_set_id": ["b4bc4302-9484-465a-090d-47e1e0360b73"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70700-101-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "70700-101-85", "marketing_start_date": "20180824"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol", "product_id": "70700-101_0b7a2fac-2281-4c64-29aa-5e0d05d49236", "dosage_form": "KIT", "product_ndc": "70700-101", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol", "application_number": "ANDA209609", "marketing_category": "ANDA", "marketing_start_date": "20180824", "listing_expiration_date": "20261231"}