mono-linyah

Generic: norgestimate and ethinyl estradiol

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mono-linyah
Generic Name norgestimate and ethinyl estradiol
Labeler northstar rx llc
Dosage Form KIT
Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-360
Product ID 16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090523
Listing Expiration 2026-12-31
Marketing Start 2012-05-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714360
Hyphenated Format 16714-360

Supplemental Identifiers

RxCUI
240128 748797 749860 1365899

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 mono-linyah (source: ndc)
Generic Name norgestimate and ethinyl estradiol (source: ndc)
Application Number ANDA090523 (source: ndc)

Resolved Composition

Strengths
  • 0.250 mg
  • 0.035 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (4)

16714-360-01 1 BLISTER PACK in 1 PACKET (16714-360-01) / 1 KIT in 1 BLISTER PACK 16714-360-02 1 BLISTER PACK in 1 CARTON (16714-360-02) / 1 KIT in 1 BLISTER PACK 16714-360-03 3 BLISTER PACK in 1 CARTON (16714-360-03) / 1 KIT in 1 BLISTER PACK 16714-360-04 6 BLISTER PACK in 1 CARTON (16714-360-04) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Mono-Linyah ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e9022492-18a7-44e1-9a89-45a4c06c72f1", "openfda": {"rxcui": ["240128", "748797", "749860", "1365899"], "spl_set_id": ["84a20017-344b-4684-a915-c85a55fcbbcb"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (16714-360-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-360-01", "marketing_start_date": "20120523"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-360-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-360-02", "marketing_start_date": "20120523"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16714-360-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-360-03", "marketing_start_date": "20120523"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (16714-360-04)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-360-04", "marketing_start_date": "20120523"}], "brand_name": "Mono-Linyah", "product_id": "16714-360_e9022492-18a7-44e1-9a89-45a4c06c72f1", "dosage_form": "KIT", "product_ndc": "16714-360", "generic_name": "norgestimate and ethinyl estradiol", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mono-Linyah", "application_number": "ANDA090523", "marketing_category": "ANDA", "marketing_start_date": "20120523", "listing_expiration_date": "20261231"}