plan b one-step

Generic: levonorgestrel

Labeler: foundation consumer healthcare llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name plan b one-step
Generic Name levonorgestrel
Labeler foundation consumer healthcare llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Foundation Consumer Healthcare LLC

Identifiers & Regulatory

Product NDC 69536-162
Product ID 69536-162_a0190797-2a39-47be-803b-bec877085166
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 69536162
Hyphenated Format 69536-162

Supplemental Identifiers

RxCUI
483325 858079
UPC
0369536146195 0369536162881
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 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 (69536-162-88) / 1 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-99) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

69536-162-88 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-88) / 1 TABLET in 1 BLISTER PACK 69536-162-99 1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-99) / 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": "a0190797-2a39-47be-803b-bec877085166", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0369536146195", "0369536162881"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "858079"], "spl_set_id": ["6ce6b40e-14ac-47bd-a648-ddf9e452e559"], "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": ["Foundation Consumer Healthcare LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-88)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "69536-162-88", "marketing_start_date": "20180510"}, {"sample": false, "description": "1 BLISTER PACK in 1 BOX, UNIT-DOSE (69536-162-99)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "69536-162-99", "marketing_start_date": "20190815"}], "brand_name": "Plan B One-Step", "product_id": "69536-162_a0190797-2a39-47be-803b-bec877085166", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "69536-162", "generic_name": "levonorgestrel", "labeler_name": "Foundation Consumer Healthcare LLC", "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"}