norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Generic: norethindrone acetate and ethinyl estradiol, and ferrous fumarate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Generic Name norethindrone acetate and ethinyl estradiol, and ferrous fumarate
Labeler amneal pharmaceuticals ny llc
Dosage Form KIT
Routes
ORAL
Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 69238-1686
Product ID 69238-1686_eaacb828-e8db-45c4-882b-a6ddf46bf7f0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214292
Listing Expiration 2026-12-31
Marketing Start 2021-07-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 692381686
Hyphenated Format 69238-1686

Supplemental Identifiers

RxCUI
1421459 1421460 1421461
UPC
0369238168631

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, and ferrous fumarate (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol, and ferrous fumarate (source: ndc)
Application Number ANDA214292 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
  • 1 mg/20 mcg
source: label
Packaging
  • 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

69238-1686-3 5 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eaacb828-e8db-45c4-882b-a6ddf46bf7f0", "openfda": {"upc": ["0369238168631"], "rxcui": ["1421459", "1421460", "1421461"], "spl_set_id": ["e145ebc7-b6c0-474b-a712-c6f3b2342998"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 CARTON in 1 TRAY (69238-1686-3)  / 1 BLISTER PACK in 1 CARTON (69238-1686-6)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "69238-1686-3", "marketing_start_date": "20210726"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate", "product_id": "69238-1686_eaacb828-e8db-45c4-882b-a6ddf46bf7f0", "dosage_form": "KIT", "product_ndc": "69238-1686", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate", "application_number": "ANDA214292", "marketing_category": "ANDA", "marketing_start_date": "20210726", "listing_expiration_date": "20261231"}