incassia

Generic: norethindrone

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name incassia
Generic Name norethindrone
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

norethindrone .35 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-925
Product ID 65862-925_0caa1c4e-9536-49b0-a523-b6a6676434ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207304
Listing Expiration 2026-12-31
Marketing Start 2016-09-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862925
Hyphenated Format 65862-925

Supplemental Identifiers

RxCUI
198042 748961 2052064
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 incassia (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA207304 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-925-28) / 1 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (65862-925-85) / 1 TABLET in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (65862-925-86) / 1 TABLET in 1 BLISTER PACK
  • 1 POUCH in 1 CARTON (65862-925-87) / 1 TABLET in 1 POUCH
  • 3 POUCH in 1 CARTON (65862-925-88) / 1 TABLET in 1 POUCH
  • 6 POUCH in 1 CARTON (65862-925-92) / 1 TABLET in 1 POUCH
source: ndc

Packages (6)

65862-925-28 1 BLISTER PACK in 1 CARTON (65862-925-28) / 1 TABLET in 1 BLISTER PACK 65862-925-85 3 BLISTER PACK in 1 CARTON (65862-925-85) / 1 TABLET in 1 BLISTER PACK 65862-925-86 6 BLISTER PACK in 1 CARTON (65862-925-86) / 1 TABLET in 1 BLISTER PACK 65862-925-87 1 POUCH in 1 CARTON (65862-925-87) / 1 TABLET in 1 POUCH 65862-925-88 3 POUCH in 1 CARTON (65862-925-88) / 1 TABLET in 1 POUCH 65862-925-92 6 POUCH in 1 CARTON (65862-925-92) / 1 TABLET in 1 POUCH

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Incassia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0caa1c4e-9536-49b0-a523-b6a6676434ba", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "2052064"], "spl_set_id": ["0b87cef0-610c-469d-92ba-4007f4bc3878"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Progestin [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-925-28)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "65862-925-28", "marketing_start_date": "20160923"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-925-85)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "65862-925-85", "marketing_start_date": "20160923"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (65862-925-86)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "65862-925-86", "marketing_start_date": "20160923"}, {"sample": false, "description": "1 POUCH in 1 CARTON (65862-925-87)  / 1 TABLET in 1 POUCH", "package_ndc": "65862-925-87", "marketing_start_date": "20160923"}, {"sample": false, "description": "3 POUCH in 1 CARTON (65862-925-88)  / 1 TABLET in 1 POUCH", "package_ndc": "65862-925-88", "marketing_start_date": "20160923"}, {"sample": false, "description": "6 POUCH in 1 CARTON (65862-925-92)  / 1 TABLET in 1 POUCH", "package_ndc": "65862-925-92", "marketing_start_date": "20160923"}], "brand_name": "Incassia", "product_id": "65862-925_0caa1c4e-9536-49b0-a523-b6a6676434ba", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "65862-925", "generic_name": "NORETHINDRONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Incassia", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA207304", "marketing_category": "ANDA", "marketing_start_date": "20160923", "listing_expiration_date": "20261231"}