viorele

Generic: desogestrel and ethinyl estradiol and ethinyl estradiol

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name viorele
Generic Name desogestrel and ethinyl estradiol and ethinyl estradiol
Labeler glenmark pharmaceuticals inc., usa
Dosage Form KIT
Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-318
Product ID 68462-318_985b7e31-558c-4e49-b6ff-a0951bc4a947
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091346
Listing Expiration 2027-12-31
Marketing Start 2012-04-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462318
Hyphenated Format 68462-318

Supplemental Identifiers

RxCUI
248310 249357 748797 759743 1252016

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 viorele (source: ndc)
Generic Name desogestrel and ethinyl estradiol and ethinyl estradiol (source: ndc)
Application Number ANDA091346 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.02 mg
  • 0.01 mg
source: label
Packaging
  • 3 BLISTER PACK in 1 CARTON (68462-318-29) / 1 KIT in 1 BLISTER PACK (68462-318-84)
source: ndc

Packages (1)

68462-318-29 3 BLISTER PACK in 1 CARTON (68462-318-29) / 1 KIT in 1 BLISTER PACK (68462-318-84)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VIORELE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "985b7e31-558c-4e49-b6ff-a0951bc4a947", "openfda": {"rxcui": ["248310", "249357", "748797", "759743", "1252016"], "spl_set_id": ["39988aa6-8f68-40e8-9bdd-c40a3bdaad61"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68462-318-29)  / 1 KIT in 1 BLISTER PACK (68462-318-84)", "package_ndc": "68462-318-29", "marketing_start_date": "20120404"}], "brand_name": "VIORELE", "product_id": "68462-318_985b7e31-558c-4e49-b6ff-a0951bc4a947", "dosage_form": "KIT", "product_ndc": "68462-318", "generic_name": "Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VIORELE", "application_number": "ANDA091346", "marketing_category": "ANDA", "marketing_start_date": "20120404", "listing_expiration_date": "20271231"}