zovia 1/35

Generic: ethynodiol diacetate and ethinyl estradiol tablets

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zovia 1/35
Generic Name ethynodiol diacetate and ethinyl estradiol tablets
Labeler mayne pharma inc.
Dosage Form KIT
Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 51862-894
Product ID 51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209548
Listing Expiration 2026-12-31
Marketing Start 2020-10-16

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862894
Hyphenated Format 51862-894

Supplemental Identifiers

RxCUI
310228 748797 748804 748859

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 zovia 1/35 (source: ndc)
Generic Name ethynodiol diacetate and ethinyl estradiol tablets (source: ndc)
Application Number ANDA209548 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 35 mcg
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

51862-894-01 1 BLISTER PACK in 1 PACKET (51862-894-01) / 1 KIT in 1 BLISTER PACK 51862-894-03 3 BLISTER PACK in 1 CARTON (51862-894-03) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Zovia 1/35 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "cf45efe7-7a61-4d1e-a3d4-d43c65911c4c", "openfda": {"rxcui": ["310228", "748797", "748804", "748859"], "spl_set_id": ["d0d2a9e9-e9ce-4a42-b429-5c1f9a544795"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (51862-894-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "51862-894-01", "marketing_start_date": "20201016"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (51862-894-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "51862-894-03", "marketing_start_date": "20201016"}], "brand_name": "Zovia 1/35", "product_id": "51862-894_cf45efe7-7a61-4d1e-a3d4-d43c65911c4c", "dosage_form": "KIT", "product_ndc": "51862-894", "generic_name": "Ethynodiol Diacetate and Ethinyl Estradiol Tablets", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zovia 1/35", "application_number": "ANDA209548", "marketing_category": "ANDA", "marketing_start_date": "20201016", "listing_expiration_date": "20261231"}