julie

Generic: levonorgestrel

Labeler: julie products inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name julie
Generic Name levonorgestrel
Labeler julie products inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
Julie Products Inc.

Identifiers & Regulatory

Product NDC 82791-538
Product ID 82791-538_5ea0818f-2238-4f12-b58a-4bed37ef798b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206867
Listing Expiration 2026-12-31
Marketing Start 2022-07-15

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 82791538
Hyphenated Format 82791-538

Supplemental Identifiers

RxCUI
483325 2606549
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 julie (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA206867 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (82791-538-01) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

82791-538-01 1 BLISTER PACK in 1 CARTON (82791-538-01) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

Julie ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5ea0818f-2238-4f12-b58a-4bed37ef798b", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2606549"], "spl_set_id": ["8fb303ec-3b6a-47ac-9ad9-83ab6f0d6ae8"], "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": ["Julie Products Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (82791-538-01)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "82791-538-01", "marketing_start_date": "20220715"}], "brand_name": "Julie", "product_id": "82791-538_5ea0818f-2238-4f12-b58a-4bed37ef798b", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "82791-538", "generic_name": "Levonorgestrel", "labeler_name": "Julie Products Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Julie", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA206867", "marketing_category": "ANDA", "marketing_start_date": "20220715", "listing_expiration_date": "20261231"}