optionelle

Generic: levonorgestrel tablet, 1.5 mg

Labeler: strides pharma inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name optionelle
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 59556-286
Product ID 59556-286_18f8537b-15ab-4597-aa74-396d684ff624
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202380
Listing Expiration 2026-12-31
Marketing Start 2022-09-15

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 59556286
Hyphenated Format 59556-286

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 optionelle (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 (59556-286-01) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

59556-286-01 1 BLISTER PACK in 1 CARTON (59556-286-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Optionelle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "18f8537b-15ab-4597-aa74-396d684ff624", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325"], "spl_set_id": ["1c7e849c-6392-48a6-9214-907325a012e2"], "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 (59556-286-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "59556-286-01", "marketing_start_date": "20220915"}], "brand_name": "Optionelle", "product_id": "59556-286_18f8537b-15ab-4597-aa74-396d684ff624", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "59556-286", "generic_name": "Levonorgestrel Tablet, 1.5 mg", "labeler_name": "Strides Pharma Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Optionelle", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202380", "marketing_category": "ANDA", "marketing_start_date": "20220915", "listing_expiration_date": "20261231"}