norethindrone

Generic: norethindrone

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name norethindrone
Generic Name norethindrone
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-175
Product ID 82804-175_bbd54f1e-2d48-4efa-a57e-7fa7b478c457
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091325
Listing Expiration 2027-12-31
Marketing Start 2020-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804175
Hyphenated Format 82804-175

Supplemental Identifiers

RxCUI
198042 748961
UPC
0382804175284
UNII
T18F433X4S
NUI
M0447349 N0000175602

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 norethindrone (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA091325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BAG (82804-175-28) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

82804-175-28 1 BLISTER PACK in 1 BAG (82804-175-28) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

NORETHINDRONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bbd54f1e-2d48-4efa-a57e-7fa7b478c457", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0382804175284"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961"], "spl_set_id": ["bbd54f1e-2d48-4efa-a57e-7fa7b478c457"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BAG (82804-175-28)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "82804-175-28", "marketing_start_date": "20201111"}], "brand_name": "NORETHINDRONE", "product_id": "82804-175_bbd54f1e-2d48-4efa-a57e-7fa7b478c457", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "82804-175", "generic_name": "NORETHINDRONE", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NORETHINDRONE", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA091325", "marketing_category": "ANDA", "marketing_start_date": "20201111", "listing_expiration_date": "20271231"}