jencycla

Generic: norethindrone

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name jencycla
Generic Name norethindrone
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-877
Product ID 68180-877_223eb6ba-f676-4483-9511-55ab00a1debc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091323
Listing Expiration 2026-12-31
Marketing Start 2020-07-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180877
Hyphenated Format 68180-877

Supplemental Identifiers

RxCUI
198042 748961 1422896
UPC
0368180877714
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 jencycla (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA091323 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68180-877-73) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

68180-877-73 1 BLISTER PACK in 1 CARTON (68180-877-73) / 28 TABLET in 1 BLISTER PACK

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Jencycla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "223eb6ba-f676-4483-9511-55ab00a1debc", "openfda": {"nui": ["M0447349", "N0000175602"], "upc": ["0368180877714"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "1422896"], "spl_set_id": ["e91e7bdd-2984-4332-9b0b-04322792d7f6"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68180-877-73)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "68180-877-73", "marketing_start_date": "20200707"}], "brand_name": "Jencycla", "product_id": "68180-877_223eb6ba-f676-4483-9511-55ab00a1debc", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68180-877", "generic_name": "norethindrone", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Jencycla", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA091323", "marketing_category": "ANDA", "marketing_start_date": "20200707", "listing_expiration_date": "20261231"}