orquidea

Generic: norethindrone

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

Drug Facts

Product Profile

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

norethindrone .35 mg/1

Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-316
Product ID 70700-316_a54bf859-7035-5948-0a50-9c42bb791c9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201483
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 70700316
Hyphenated Format 70700-316

Supplemental Identifiers

RxCUI
198042 748961 2704560
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 orquidea (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA201483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70700-316-85 3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Orquidea ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a54bf859-7035-5948-0a50-9c42bb791c9f", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "2704560"], "spl_set_id": ["6e9f61a1-93ff-291a-bea8-9307a3b0378e"], "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 (70700-316-85)  / 1 BLISTER PACK in 1 POUCH (70700-316-84)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "70700-316-85", "marketing_start_date": "20250129"}], "brand_name": "Orquidea", "product_id": "70700-316_a54bf859-7035-5948-0a50-9c42bb791c9f", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70700-316", "generic_name": "norethindrone", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Orquidea", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA201483", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}