levonorgestrel and ethinyl estradiol

Generic: levonorgestrel and ethinyl estradiol

Labeler: acella pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name levonorgestrel and ethinyl estradiol
Generic Name levonorgestrel and ethinyl estradiol
Labeler acella pharmaceuticals
Dosage Form KIT
Manufacturer
Acella Pharmaceuticals

Identifiers & Regulatory

Product NDC 42192-623
Product ID 42192-623_18a7ed1f-bfc1-476c-9550-77f80f5feeac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208612
Listing Expiration 2026-12-31
Marketing Start 2023-08-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42192623
Hyphenated Format 42192-623

Supplemental Identifiers

RxCUI
242297 2672922 2672923

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 levonorgestrel and ethinyl estradiol (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number NDA208612 (source: ndc)

Resolved Composition

Strengths
  • 0.10 mg
  • 0.02 mg
  • 36.5 mg
  • 0.1 mg
source: label
Packaging
  • 3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

42192-623-03 3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACK 42192-623-28 1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

levonorgestrel and ethinyl estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "18a7ed1f-bfc1-476c-9550-77f80f5feeac", "openfda": {"rxcui": ["242297", "2672922", "2672923"], "spl_set_id": ["167b12a0-cdff-4081-a0a4-164482c239fa"], "manufacturer_name": ["Acella Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (42192-623-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "42192-623-03", "marketing_start_date": "20230821"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (42192-623-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "42192-623-28", "marketing_start_date": "20230821"}], "brand_name": "levonorgestrel and ethinyl estradiol", "product_id": "42192-623_18a7ed1f-bfc1-476c-9550-77f80f5feeac", "dosage_form": "KIT", "product_ndc": "42192-623", "generic_name": "levonorgestrel and ethinyl estradiol", "labeler_name": "Acella Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "levonorgestrel and ethinyl estradiol", "application_number": "NDA208612", "marketing_category": "NDA", "marketing_start_date": "20230821", "listing_expiration_date": "20261231"}