nora be

Generic: norethindrone

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name nora be
Generic Name norethindrone
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3475
Product ID 0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA017060
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803475
Hyphenated Format 0480-3475

Supplemental Identifiers

RxCUI
198042 748961 748977
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 nora be (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number NDA017060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE
source: ndc

Packages (1)

0480-3475-16 6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Nora BE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f6f53f3-b61a-45d9-94ed-d2946a17212e", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "748977"], "spl_set_id": ["426ac898-7745-4645-bf9b-bae319e260e8"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 PACKAGE in 1 CARTON (0480-3475-16)  / 28 TABLET in 1 PACKAGE", "package_ndc": "0480-3475-16", "marketing_start_date": "20231201"}], "brand_name": "Nora BE", "product_id": "0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0480-3475", "generic_name": "Norethindrone", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nora BE", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "NDA017060", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}