gallifrey

Generic: norethindrone acetate

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

Drug Facts

Product Profile

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

norethindrone acetate 5 mg/1

Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-326
Product ID 70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205278
Listing Expiration 2026-12-31
Marketing Start 2024-09-06

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700326
Hyphenated Format 70700-326

Supplemental Identifiers

RxCUI
1000405 2696255
UNII
9S44LIC7OJ

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 gallifrey (source: ndc)
Generic Name norethindrone acetate (source: ndc)
Application Number ANDA205278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE (70700-326-50)
source: ndc

Packages (1)

70700-326-50 50 TABLET in 1 BOTTLE (70700-326-50)

Ingredients (1)

norethindrone acetate (5 mg/1)

Linked Drug Pages (1)

Gallifrey ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "87e7c941-eb02-5980-fc0e-08aee9b00f75", "openfda": {"unii": ["9S44LIC7OJ"], "rxcui": ["1000405", "2696255"], "spl_set_id": ["26130af6-221b-2349-81b6-0c0132d6e524"], "manufacturer_name": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE (70700-326-50)", "package_ndc": "70700-326-50", "marketing_start_date": "20240906"}], "brand_name": "Gallifrey", "product_id": "70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70700-326", "generic_name": "Norethindrone Acetate", "labeler_name": "Xiromed LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gallifrey", "active_ingredients": [{"name": "NORETHINDRONE ACETATE", "strength": "5 mg/1"}], "application_number": "ANDA205278", "marketing_category": "ANDA", "marketing_start_date": "20240906", "listing_expiration_date": "20261231"}