kyleena

Generic: levonorgestrel

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name kyleena
Generic Name levonorgestrel
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form INTRAUTERINE DEVICE
Routes
INTRAUTERINE
Active Ingredients

levonorgestrel 19.5 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-424
Product ID 50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208224
Listing Expiration 2026-12-31
Marketing Start 2016-09-19

Pharmacologic Class

Established (EPC)
progestin [epc] progestin-containing intrauterine system [epc]
Chemical Structure
progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419424
Hyphenated Format 50419-424

Supplemental Identifiers

RxCUI
1811886 1856546
UNII
5W7SIA7YZW
NUI
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 kyleena (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number NDA208224 (source: ndc)
Routes
INTRAUTERINE
source: ndc

Resolved Composition

Strengths
  • 19.5 mg/1
source: ndc
Packaging
  • 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)
  • 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)
  • 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)
source: ndc

Packages (3)

50419-424-01 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01) 50419-424-08 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08) 50419-424-71 1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)

Ingredients (1)

levonorgestrel (19.5 mg/1)

Linked Drug Pages (1)

Kyleena ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAUTERINE"], "spl_id": "e22aea7f-9d28-426d-879a-4723fa76f2c2", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["1811886", "1856546"], "spl_set_id": ["2e07c155-21e1-4781-9633-ce8bddd47080"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-01)", "package_ndc": "50419-424-01", "marketing_start_date": "20160919"}, {"sample": false, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-08)", "package_ndc": "50419-424-08", "marketing_start_date": "20160919"}, {"sample": true, "description": "1 INTRAUTERINE DEVICE in 1 CARTON (50419-424-71)", "package_ndc": "50419-424-71", "marketing_start_date": "20160919"}], "brand_name": "Kyleena", "product_id": "50419-424_e22aea7f-9d28-426d-879a-4723fa76f2c2", "dosage_form": "INTRAUTERINE DEVICE", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "50419-424", "generic_name": "Levonorgestrel", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kyleena", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "19.5 mg/1"}], "application_number": "NDA208224", "marketing_category": "NDA", "marketing_start_date": "20160919", "listing_expiration_date": "20261231"}