nortrel 21 day (0555-9009)

Drug Facts

Product Profile

Brand Name nortrel 21 day

Generic Name norethindrone and ethinyl estradiol

Labeler teva pharmaceuticals usa, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

ethinyl estradiol .035 mg/1, norethindrone 1 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9009

Product ID 0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA072693

Listing Expiration 2027-12-31

Marketing Start 2001-06-13

Pharmacologic Class

Established (EPC)

estrogen [epc] progestin [epc]

Mechanism of Action

estrogen receptor agonists [moa]

Chemical Structure

progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05559009

Hyphenated Format 0555-9009

Supplemental Identifiers

RxCUI

310463 312033 748797 749858 749869 749879 751868 751870 751871

UNII

423D2T571U T18F433X4S

NUI

N0000175825 N0000000100 M0447349 N0000175602

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 nortrel 21 day (source: ndc)

Generic Name norethindrone and ethinyl estradiol (source: ndc)

Application Number ANDA072693 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

.035 mg/1
1 mg/1

source: ndc

Packaging

3 POUCH in 1 CARTON (0555-9009-42) / 1 BLISTER PACK in 1 POUCH (0555-9009-80) / 21 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

0555-9009-42 3 POUCH in 1 CARTON (0555-9009-42) / 1 BLISTER PACK in 1 POUCH (0555-9009-80) / 21 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (.035 mg/1) norethindrone (1 mg/1)

Linked Drug Pages (1)

Nortrel 28 Day, Nortrel 21 Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9ac007e4-792d-4122-8daf-456dea28f82f", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "T18F433X4S"], "rxcui": ["310463", "312033", "748797", "749858", "749869", "749879", "751868", "751870", "751871"], "spl_set_id": ["140c50d6-c931-423a-9aa0-526eae7ab93c"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (0555-9009-42)  / 1 BLISTER PACK in 1 POUCH (0555-9009-80)  / 21 TABLET in 1 BLISTER PACK", "package_ndc": "0555-9009-42", "marketing_start_date": "20010613"}], "brand_name": "Nortrel 21 Day", "product_id": "0555-9009_9ac007e4-792d-4122-8daf-456dea28f82f", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0555-9009", "generic_name": "Norethindrone and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortrel", "brand_name_suffix": "21 Day", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".035 mg/1"}, {"name": "NORETHINDRONE", "strength": "1 mg/1"}], "application_number": "ANDA072693", "marketing_category": "ANDA", "marketing_start_date": "20010613", "listing_expiration_date": "20271231"}