emzahh

Generic: norethindrone

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

Drug Facts

Product Profile

Brand Name emzahh
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 59651-136
Product ID 59651-136_b785dba5-f0b0-4f74-8845-e845432932c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216796
Listing Expiration 2026-12-31
Marketing Start 2023-01-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651136
Hyphenated Format 59651-136

Supplemental Identifiers

RxCUI
198042 748961 2626828
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 emzahh (source: ndc)
Generic Name norethindrone (source: ndc)
Application Number ANDA216796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACK
  • 3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCH
  • 6 POUCH in 1 CARTON (59651-136-92) / 1 TABLET in 1 POUCH
source: ndc

Packages (3)

59651-136-28 1 BLISTER PACK in 1 CARTON (59651-136-28) / 1 TABLET in 1 BLISTER PACK 59651-136-88 3 POUCH in 1 CARTON (59651-136-88) / 1 TABLET in 1 POUCH 59651-136-92 6 POUCH in 1 CARTON (59651-136-92) / 1 TABLET in 1 POUCH

Ingredients (1)

norethindrone (.35 mg/1)

Linked Drug Pages (1)

Emzahh ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b785dba5-f0b0-4f74-8845-e845432932c0", "openfda": {"nui": ["M0447349", "N0000175602"], "unii": ["T18F433X4S"], "rxcui": ["198042", "748961", "2626828"], "spl_set_id": ["197d31d3-eec8-49c7-9640-918ff138fea2"], "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 (59651-136-28)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "59651-136-28", "marketing_start_date": "20230106"}, {"sample": false, "description": "3 POUCH in 1 CARTON (59651-136-88)  / 1 TABLET in 1 POUCH", "package_ndc": "59651-136-88", "marketing_start_date": "20230106"}, {"sample": false, "description": "6 POUCH in 1 CARTON (59651-136-92)  / 1 TABLET in 1 POUCH", "package_ndc": "59651-136-92", "marketing_start_date": "20230106"}], "brand_name": "Emzahh", "product_id": "59651-136_b785dba5-f0b0-4f74-8845-e845432932c0", "dosage_form": "TABLET", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "59651-136", "generic_name": "NORETHINDRONE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Emzahh", "active_ingredients": [{"name": "NORETHINDRONE", "strength": ".35 mg/1"}], "application_number": "ANDA216796", "marketing_category": "ANDA", "marketing_start_date": "20230106", "listing_expiration_date": "20261231"}