plan b one-step (50090-5978)

Drug Facts

Product Profile

Brand Name plan b one-step

Generic Name levonorgestrel

Labeler a-s medication solutions

Dosage Form TABLET

Routes

ORAL

Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5978

Product ID 50090-5978_ed3f7b10-a3ca-45b2-94ae-ba22560450f0

Product Type HUMAN OTC DRUG

Marketing Category NDA

Application Number NDA021998

Listing Expiration 2026-12-31

Marketing Start 2018-05-10

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 500905978

Hyphenated Format 50090-5978

Supplemental Identifiers

RxCUI

483325 858079

UNII

5W7SIA7YZW

NUI

N0000175830 M0447349 N0000175602 N0000175832

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 plan b one-step (source: ndc)

Generic Name levonorgestrel (source: ndc)

Application Number NDA021998 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

1.5 mg/1

source: ndc

Packaging

1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (1)

50090-5978-0 1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Plan B One-Step ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ed3f7b10-a3ca-45b2-94ae-ba22560450f0", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "858079"], "spl_set_id": ["fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5978-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "50090-5978-0", "marketing_start_date": "20220505"}], "brand_name": "Plan B One-Step", "product_id": "50090-5978_ed3f7b10-a3ca-45b2-94ae-ba22560450f0", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "50090-5978", "generic_name": "levonorgestrel", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Plan B One-Step", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "NDA021998", "marketing_category": "NDA", "marketing_start_date": "20180510", "listing_expiration_date": "20261231"}