levonorgestrel tablet, 1.5 mg (59556-282)

Drug Facts

Product Profile

Brand Name levonorgestrel tablet, 1.5 mg

Generic Name levonorgestrel tablet, 1.5 mg

Labeler strides pharma inc

Dosage Form TABLET

Routes

ORAL

Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer

Strides Pharma Inc

Identifiers & Regulatory

Product NDC 59556-282

Product ID 59556-282_7a2ca863-fe8b-4ee6-9a63-40276db84b77

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA202380

Listing Expiration 2026-12-31

Marketing Start 2022-09-13

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 59556282

Hyphenated Format 59556-282

Supplemental Identifiers

RxCUI

483325

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 tablet, 1.5 mg (source: ndc)

Generic Name levonorgestrel tablet, 1.5 mg (source: ndc)

Application Number ANDA202380 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1.5 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 CARTON (59556-282-01) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

59556-282-01 1 BLISTER PACK in 1 CARTON (59556-282-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Levonorgestrel Tablet, 1.5 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "7a2ca863-fe8b-4ee6-9a63-40276db84b77", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["98f6367e-14d2-4c7a-9418-d996f0040d22"], "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": ["Strides Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59556-282-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "59556-282-01", "marketing_start_date": "20220913"}], "brand_name": "Levonorgestrel Tablet, 1.5 mg", "product_id": "59556-282_7a2ca863-fe8b-4ee6-9a63-40276db84b77", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "59556-282", "generic_name": "Levonorgestrel Tablet, 1.5 mg", "labeler_name": "Strides Pharma Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Levonorgestrel Tablet, 1.5 mg", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202380", "marketing_category": "ANDA", "marketing_start_date": "20220913", "listing_expiration_date": "20261231"}