levonorgestrel

Generic: levonorgestrel

Labeler: rugby laboratories
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name levonorgestrel
Generic Name levonorgestrel
Labeler rugby laboratories
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Rugby Laboratories

Identifiers & Regulatory

Product NDC 0536-1142
Product ID 0536-1142_bea85d01-936e-46f6-8037-b60d0e39dd05
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202635
Listing Expiration 2026-12-31
Marketing Start 2017-11-01

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 05361142
Hyphenated Format 0536-1142

Supplemental Identifiers

RxCUI
483325
UPC
0064674000087
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 levonorgestrel (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA202635 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0536-1142-63) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0536-1142-63 1 BLISTER PACK in 1 CARTON (0536-1142-63) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Levonorgestrel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bea85d01-936e-46f6-8037-b60d0e39dd05", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0064674000087"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["bea85d01-936e-46f6-8037-b60d0e39dd05"], "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": ["Rugby Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0536-1142-63)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0536-1142-63", "marketing_start_date": "20171101"}], "brand_name": "Levonorgestrel", "product_id": "0536-1142_bea85d01-936e-46f6-8037-b60d0e39dd05", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "0536-1142", "generic_name": "Levonorgestrel", "labeler_name": "Rugby Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Levonorgestrel", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202635", "marketing_category": "ANDA", "marketing_start_date": "20171101", "listing_expiration_date": "20261231"}