nylia 1/35

Generic: norethindrone and ethinyl estradiol

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nylia 1/35
Generic Name norethindrone and ethinyl estradiol
Labeler aurobindo pharma limited
Dosage Form KIT
Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-898
Product ID 65862-898_ea0b61da-d6b9-4ad7-85b4-5c3afd6e32b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207056
Listing Expiration 2026-12-31
Marketing Start 2016-10-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862898
Hyphenated Format 65862-898

Supplemental Identifiers

RxCUI
312033 748797 749858 1856402

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 nylia 1/35 (source: ndc)
Generic Name norethindrone and ethinyl estradiol (source: ndc)
Application Number ANDA207056 (source: ndc)

Resolved Composition

Strengths
  • 1 mg/0.035 mg
  • 1 mg
  • 0.035 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (65862-898-88) / 1 BLISTER PACK in 1 POUCH (65862-898-28) / 1 KIT in 1 BLISTER PACK
  • 6 POUCH in 1 CARTON (65862-898-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (2)

65862-898-88 3 POUCH in 1 CARTON (65862-898-88) / 1 BLISTER PACK in 1 POUCH (65862-898-28) / 1 KIT in 1 BLISTER PACK 65862-898-92 6 POUCH in 1 CARTON (65862-898-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Nylia 1/35 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "ea0b61da-d6b9-4ad7-85b4-5c3afd6e32b0", "openfda": {"rxcui": ["312033", "748797", "749858", "1856402"], "spl_set_id": ["b31bd776-3926-4b77-aa29-f5a8eef611aa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (65862-898-88)  / 1 BLISTER PACK in 1 POUCH (65862-898-28)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-898-88", "marketing_start_date": "20161021"}, {"sample": false, "description": "6 POUCH in 1 CARTON (65862-898-92)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-898-92", "marketing_start_date": "20161021"}], "brand_name": "Nylia 1/35", "product_id": "65862-898_ea0b61da-d6b9-4ad7-85b4-5c3afd6e32b0", "dosage_form": "KIT", "product_ndc": "65862-898", "generic_name": "Norethindrone and Ethinyl Estradiol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nylia 1/35", "application_number": "ANDA207056", "marketing_category": "ANDA", "marketing_start_date": "20161021", "listing_expiration_date": "20261231"}