wera

Generic: norethindrone and ethinyl estradiol

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

Drug Facts

Product Profile

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

Identifiers & Regulatory

Product NDC 16714-370
Product ID 16714-370_9ec532bb-e9c2-4275-8406-c6dcfc1b924a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091204
Listing Expiration 2026-12-31
Marketing Start 2012-03-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714370
Hyphenated Format 16714-370

Supplemental Identifiers

RxCUI
310463 748797 749879 1300911

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 wera (source: ndc)
Generic Name norethindrone and ethinyl estradiol (source: ndc)
Application Number ANDA091204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.5 mg
  • 0.035 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (16714-370-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (16714-370-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (16714-370-03) / 1 KIT in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (16714-370-04) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (4)

16714-370-01 1 BLISTER PACK in 1 PACKET (16714-370-01) / 1 KIT in 1 BLISTER PACK 16714-370-02 1 BLISTER PACK in 1 CARTON (16714-370-02) / 1 KIT in 1 BLISTER PACK 16714-370-03 3 BLISTER PACK in 1 CARTON (16714-370-03) / 1 KIT in 1 BLISTER PACK 16714-370-04 6 BLISTER PACK in 1 CARTON (16714-370-04) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Wera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9ec532bb-e9c2-4275-8406-c6dcfc1b924a", "openfda": {"rxcui": ["310463", "748797", "749879", "1300911"], "spl_set_id": ["638e4f36-1a27-4220-8ec9-3fa9d9b36c11"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (16714-370-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-370-01", "marketing_start_date": "20120327"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-370-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-370-02", "marketing_start_date": "20120327"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16714-370-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-370-03", "marketing_start_date": "20120327"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (16714-370-04)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-370-04", "marketing_start_date": "20120327"}], "brand_name": "Wera", "product_id": "16714-370_9ec532bb-e9c2-4275-8406-c6dcfc1b924a", "dosage_form": "KIT", "product_ndc": "16714-370", "generic_name": "norethindrone and ethinyl estradiol", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Wera", "application_number": "ANDA091204", "marketing_category": "ANDA", "marketing_start_date": "20120327", "listing_expiration_date": "20261231"}