sharobel

Generic: norethindrone

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

Drug Facts

Product Profile

Brand Name sharobel
Generic Name norethindrone
Labeler northstar rx llc
Dosage Form KIT
Manufacturer
Northstar Rx LLC

Identifiers & Regulatory

Product NDC 16714-441
Product ID 16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200961
Listing Expiration 2026-12-31
Marketing Start 2013-09-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714441
Hyphenated Format 16714-441

Supplemental Identifiers

RxCUI
198042 748961 1539955

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 sharobel (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA200961 (source: ndc)

Resolved Composition

Strengths
  • 0.35 mg
source: label
Packaging
  • 1 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (16714-441-04) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (4)

16714-441-01 1 BLISTER PACK in 1 PACKET (16714-441-01) / 1 KIT in 1 BLISTER PACK 16714-441-02 1 BLISTER PACK in 1 CARTON (16714-441-02) / 1 KIT in 1 BLISTER PACK 16714-441-03 3 BLISTER PACK in 1 CARTON (16714-441-03) / 1 KIT in 1 BLISTER PACK 16714-441-04 6 BLISTER PACK in 1 CARTON (16714-441-04) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

SHAROBEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "bc5880ea-5359-4f40-a2e5-7af0b1131a9c", "openfda": {"rxcui": ["198042", "748961", "1539955"], "spl_set_id": ["a96f5194-ad2a-4783-a9a9-22a288caff25"], "manufacturer_name": ["Northstar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 PACKET (16714-441-01)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-441-01", "marketing_start_date": "20130913"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-441-02)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-441-02", "marketing_start_date": "20200101"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16714-441-03)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-441-03", "marketing_start_date": "20200101"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (16714-441-04)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "16714-441-04", "marketing_start_date": "20130913"}], "brand_name": "SHAROBEL", "product_id": "16714-441_bc5880ea-5359-4f40-a2e5-7af0b1131a9c", "dosage_form": "KIT", "product_ndc": "16714-441", "generic_name": "Norethindrone", "labeler_name": "Northstar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SHAROBEL", "application_number": "ANDA200961", "marketing_category": "ANDA", "marketing_start_date": "20130913", "listing_expiration_date": "20261231"}