opcicon one-step

Generic: levonorgestrel

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name opcicon one-step
Generic Name levonorgestrel
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-718
Product ID 62756-718_61d03fd1-1f93-4f6c-940c-e436ab1b63a9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA202635
Listing Expiration 2026-12-31
Marketing Start 2014-09-12

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 62756718
Hyphenated Format 62756-718

Supplemental Identifiers

RxCUI
483325 1549091
UPC
0362756718609
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 opcicon one-step (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 (62756-718-60) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

62756-718-60 1 BLISTER PACK in 1 CARTON (62756-718-60) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Opcicon One-Step ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "61d03fd1-1f93-4f6c-940c-e436ab1b63a9", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0362756718609"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "1549091"], "spl_set_id": ["b67ca313-561e-471f-baf3-257b7e253c75"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (62756-718-60)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "62756-718-60", "marketing_start_date": "20140912"}], "brand_name": "Opcicon One-Step", "product_id": "62756-718_61d03fd1-1f93-4f6c-940c-e436ab1b63a9", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine Device [EPC]"], "product_ndc": "62756-718", "generic_name": "levonorgestrel", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Opcicon One-Step", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA202635", "marketing_category": "ANDA", "marketing_start_date": "20140912", "listing_expiration_date": "20261231"}