meleya

Generic: norethindrone

Labeler: xiromed llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meleya
Generic Name norethindrone
Labeler xiromed llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-317
Product ID 70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200980
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Pharmacologic Class

Established (EPC)
progestin [epc]
Chemical Structure
progesterone congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700317
Hyphenated Format 70700-317

Supplemental Identifiers

RxCUI
198042 748961 2716571
UNII
T18F433X4S
NUI
M0447349 N0000175602

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 meleya (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA200980 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70700-317-85 3 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

MELEYA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a3bb0699-e518-4526-e81e-df5e1afefe38", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "2716571"], "spl_set_id": ["534c5717-382c-4109-3208-e21b32e4c4c9"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70700-317-85)  / 1 BLISTER PACK in 1 POUCH (70700-317-84)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "70700-317-85", "marketing_start_date": "20250129"}], "brand_name": "MELEYA", "product_id": "70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70700-317", "generic_name": "Norethindrone", "labeler_name": "Xiromed LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MELEYA", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA200980", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}