amethyst

Generic: levonorgestrel and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name amethyst
Generic Name levonorgestrel and ethinyl estradiol
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ethinyl estradiol 20 ug/1, levonorgestrel 90 ug/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3472
Product ID 0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079218
Listing Expiration 2026-12-31
Marketing Start 2023-03-01

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc] progestin-containing intrauterine system [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803472
Hyphenated Format 0480-3472

Supplemental Identifiers

RxCUI
722152 751553 1112715
UNII
423D2T571U 5W7SIA7YZW
NUI
N0000175825 N0000000100 N0000175830 M0447349 N0000175602 N0000175832

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 amethyst (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA079218 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 ug/1
  • 90 ug/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0480-3472-24 1 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK

Ingredients (2)

ethinyl estradiol (20 ug/1) levonorgestrel (90 ug/1)

Linked Drug Pages (1)

Amethyst ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e70f2946-fc53-487c-b37a-d11ee6751735", "openfda": {"nui": ["N0000175825", "N0000000100", "N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["423D2T571U", "5W7SIA7YZW"], "rxcui": ["722152", "751553", "1112715"], "spl_set_id": ["99073fe0-eac8-44dd-abe6-623fa67d9e79"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (0480-3472-24)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK", "package_ndc": "0480-3472-24", "marketing_start_date": "20230301"}], "brand_name": "Amethyst", "product_id": "0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735", "dosage_form": "TABLET", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "0480-3472", "generic_name": "Levonorgestrel and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amethyst", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "20 ug/1"}, {"name": "LEVONORGESTREL", "strength": "90 ug/1"}], "application_number": "ANDA079218", "marketing_category": "ANDA", "marketing_start_date": "20230301", "listing_expiration_date": "20261231"}