shewise

Generic: levonorgestrel

Labeler: glenmark therapeutics inc., usa
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name shewise
Generic Name levonorgestrel
Labeler glenmark therapeutics inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

levonorgestrel 1.5 mg/1

Manufacturer
GLENMARK THERAPEUTICS INC., USA

Identifiers & Regulatory

Product NDC 72657-108
Product ID 72657-108_88548851-6506-4cb2-8636-a30be9ee562e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207044
Listing Expiration 2027-12-31
Marketing Start 2022-07-29

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 72657108
Hyphenated Format 72657-108

Supplemental Identifiers

RxCUI
483325 2730936
UPC
0372657123112 0372657108126
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 shewise (source: ndc)
Generic Name levonorgestrel (source: ndc)
Application Number ANDA207044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

72657-108-12 1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

levonorgestrel (1.5 mg/1)

Linked Drug Pages (1)

SheWise ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "88548851-6506-4cb2-8636-a30be9ee562e", "openfda": {"nui": ["N0000175830", "M0447349", "N0000175602", "N0000175832"], "upc": ["0372657123112", "0372657108126"], "unii": ["5W7SIA7YZW"], "rxcui": ["483325", "2730936"], "spl_set_id": ["7be13a7e-b4ff-4fe1-82a6-f9914596d72a"], "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": ["GLENMARK THERAPEUTICS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (72657-108-12)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "72657-108-12", "marketing_start_date": "20220729"}], "brand_name": "SheWise", "product_id": "72657-108_88548851-6506-4cb2-8636-a30be9ee562e", "dosage_form": "TABLET", "pharm_class": ["Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "72657-108", "generic_name": "Levonorgestrel", "labeler_name": "GLENMARK THERAPEUTICS INC., USA", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SheWise", "active_ingredients": [{"name": "LEVONORGESTREL", "strength": "1.5 mg/1"}], "application_number": "ANDA207044", "marketing_category": "ANDA", "marketing_start_date": "20220729", "listing_expiration_date": "20271231"}