balcoltra

Generic: levonorgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name balcoltra
Generic Name levonorgestrel and ethinyl estradiol
Labeler avion pharmaceuticals
Dosage Form KIT
Manufacturer
Avion Pharmaceuticals

Identifiers & Regulatory

Product NDC 75854-602
Product ID 75854-602_57bb625e-d567-432d-a6c2-44b329de9b7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208612
Listing Expiration 2026-12-31
Marketing Start 2018-04-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75854602
Hyphenated Format 75854-602

Supplemental Identifiers

RxCUI
242297 1999026 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 balcoltra (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
  • 2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (3)

75854-602-02 2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK 75854-602-03 3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK 75854-602-28 1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Balcoltra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "57bb625e-d567-432d-a6c2-44b329de9b7b", "openfda": {"rxcui": ["242297", "1999026", "2672922", "2672923"], "spl_set_id": ["752ab698-4b48-4614-8016-d1d33ee7c007"], "manufacturer_name": ["Avion Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (75854-602-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "75854-602-02", "marketing_start_date": "20180410"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (75854-602-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "75854-602-03", "marketing_start_date": "20180410"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (75854-602-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "75854-602-28", "marketing_start_date": "20180410"}], "brand_name": "Balcoltra", "product_id": "75854-602_57bb625e-d567-432d-a6c2-44b329de9b7b", "dosage_form": "KIT", "product_ndc": "75854-602", "generic_name": "levonorgestrel and ethinyl estradiol", "labeler_name": "Avion Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Balcoltra", "application_number": "NDA208612", "marketing_category": "NDA", "marketing_start_date": "20180410", "listing_expiration_date": "20261231"}