nortrel 28 day

Generic: norethindrone and ethinyl estradiol

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nortrel 28 day
Generic Name norethindrone and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9010
Product ID 0555-9010_9ac007e4-792d-4122-8daf-456dea28f82f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA072696
Listing Expiration 2027-12-31
Marketing Start 2001-06-06

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 05559010
Hyphenated Format 0555-9010

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 28 day (source: ndc)
Generic Name norethindrone and ethinyl estradiol (source: ndc)
Application Number ANDA072696 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 1 mg/0.035 mg
  • 1 mg
  • 0.035 mg
  • 0.5 mg/0.035 mg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9010-58) / 1 BLISTER PACK in 1 POUCH (0555-9010-79) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9010-58 6 POUCH in 1 CARTON (0555-9010-58) / 1 BLISTER PACK in 1 POUCH (0555-9010-79) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "6 POUCH in 1 CARTON (0555-9010-58)  / 1 BLISTER PACK in 1 POUCH (0555-9010-79)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9010-58", "marketing_start_date": "20010606"}], "brand_name": "Nortrel 28 Day", "product_id": "0555-9010_9ac007e4-792d-4122-8daf-456dea28f82f", "dosage_form": "KIT", "product_ndc": "0555-9010", "generic_name": "Norethindrone and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nortrel", "brand_name_suffix": "28 Day", "application_number": "ANDA072696", "marketing_category": "ANDA", "marketing_start_date": "20010606", "listing_expiration_date": "20271231"}