philith

Generic: norethindrone and ethinyl estradiol tablets

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

Drug Facts

Product Profile

Brand Name philith
Generic Name norethindrone and ethinyl estradiol tablets
Labeler northstar rx llc
Dosage Form KIT
Routes
ORAL
Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-347
Product ID 16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090947
Listing Expiration 2026-12-31
Marketing Start 2011-12-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714347
Hyphenated Format 16714-347

Supplemental Identifiers

RxCUI
238015 748797 749736 1235874

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 philith (source: ndc)
Generic Name norethindrone and ethinyl estradiol tablets (source: ndc)
Application Number ANDA090947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.4 mg
  • 0.035 mg
  • 1 %
  • 3 %
  • 18 %
  • 21 %
  • 28 %
  • 12 %
  • 20 %
  • 0.3 %
  • 0.4 %
  • 0.03 %
  • 0.04 %
  • 85 %
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (4)

16714-347-01 1 BLISTER PACK in 1 PACKET (16714-347-01) / 1 KIT in 1 BLISTER PACK 16714-347-02 1 BLISTER PACK in 1 CARTON (16714-347-02) / 1 KIT in 1 BLISTER PACK 16714-347-03 3 BLISTER PACK in 1 CARTON (16714-347-03) / 1 KIT in 1 BLISTER PACK 16714-347-04 6 BLISTER PACK in 1 CARTON (16714-347-04) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Philith ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bca1e775-2fc3-43df-8c55-e4e7b959f4fb", "openfda": {"rxcui": ["238015", "748797", "749736", "1235874"], "spl_set_id": ["77b8d3ef-f3ac-4148-84f0-f6cb327c9f78"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (16714-347-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-347-01", "marketing_start_date": "20111222"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-347-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-347-02", "marketing_start_date": "20111222"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16714-347-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-347-03", "marketing_start_date": "20111222"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (16714-347-04)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-347-04", "marketing_start_date": "20111222"}], "brand_name": "Philith", "product_id": "16714-347_bca1e775-2fc3-43df-8c55-e4e7b959f4fb", "dosage_form": "KIT", "product_ndc": "16714-347", "generic_name": "Norethindrone and Ethinyl Estradiol Tablets", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Philith", "application_number": "ANDA090947", "marketing_category": "ANDA", "marketing_start_date": "20111222", "listing_expiration_date": "20261231"}