ethynodiol diacetate and ethinyl estradiol

Generic: ethynodiol diacetate and ethinyl estradiol

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ethynodiol diacetate and ethinyl estradiol
Generic Name ethynodiol diacetate and ethinyl estradiol
Labeler mylan pharmaceuticals inc.
Dosage Form KIT
Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-7307
Product ID 0378-7307_58682d4f-d934-69bc-92e4-9033e1425b47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204703
Listing Expiration 2026-12-31
Marketing Start 2017-09-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03787307
Hyphenated Format 0378-7307

Supplemental Identifiers

RxCUI
310228 748797 748804

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 ethynodiol diacetate and ethinyl estradiol (source: ndc)
Generic Name ethynodiol diacetate and ethinyl estradiol (source: ndc)
Application Number ANDA204703 (source: ndc)

Resolved Composition

Strengths
  • 1 mg/35 mcg
  • 1 mg
  • 35 mcg
source: label
Packaging
  • 3 POUCH in 1 CARTON (0378-7307-53) / 1 BLISTER PACK in 1 POUCH (0378-7307-85) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0378-7307-53 3 POUCH in 1 CARTON (0378-7307-53) / 1 BLISTER PACK in 1 POUCH (0378-7307-85) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "58682d4f-d934-69bc-92e4-9033e1425b47", "openfda": {"rxcui": ["310228", "748797", "748804"], "spl_set_id": ["47263647-a9ac-40e4-83c0-d6500fa458cd"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0378-7307-53)  / 1 BLISTER PACK in 1 POUCH (0378-7307-85)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0378-7307-53", "marketing_start_date": "20170919"}], "brand_name": "ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL", "product_id": "0378-7307_58682d4f-d934-69bc-92e4-9033e1425b47", "dosage_form": "KIT", "product_ndc": "0378-7307", "generic_name": "ethynodiol diacetate and ethinyl estradiol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL", "application_number": "ANDA204703", "marketing_category": "ANDA", "marketing_start_date": "20170919", "listing_expiration_date": "20261231"}