affodel

Generic: norethindrone

Labeler: naari pte. limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name affodel
Generic Name norethindrone
Labeler naari pte. limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Naari Pte. Limited

Identifiers & Regulatory

Product NDC 79929-015
Product ID 79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206807
Listing Expiration 2026-12-31
Marketing Start 2024-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 79929015
Hyphenated Format 79929-015

Supplemental Identifiers

RxCUI
198042 748961
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 affodel (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA206807 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

79929-015-07 84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Affodel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16aaf795-d546-9f9c-e063-6394a90a09c4", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["8ec64ec8-fbc9-440d-9838-654a605d57da"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Naari Pte. Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "84 BLISTER PACK in 1 CARTON (79929-015-07)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "79929-015-07", "marketing_start_date": "20240531"}], "brand_name": "Affodel", "product_id": "79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "79929-015", "generic_name": "Norethindrone", "labeler_name": "Naari Pte. Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Affodel", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA206807", "marketing_category": "ANDA", "marketing_start_date": "20240531", "listing_expiration_date": "20261231"}