aurovela 24 fe

Generic: norethindrone acetate and ethinyl estradiol and ferrous fumarate

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

Drug Facts

Product Profile

Brand Name aurovela 24 fe
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Labeler aurobindo pharma limited
Dosage Form KIT
Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-934
Product ID 65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207504
Listing Expiration 2026-12-31
Marketing Start 2017-06-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862934
Hyphenated Format 65862-934

Supplemental Identifiers

RxCUI
259176 1358762 1359117 1927957

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 aurovela 24 fe (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA207504 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
source: label
Packaging
  • 5 POUCH in 1 CARTON (65862-934-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • 1 POUCH in 1 CARTON (65862-934-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • 3 POUCH in 1 CARTON (65862-934-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (3)

65862-934-58 5 POUCH in 1 CARTON (65862-934-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 65862-934-87 1 POUCH in 1 CARTON (65862-934-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 65862-934-88 3 POUCH in 1 CARTON (65862-934-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Aurovela 24 Fe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "8b98eb73-94c9-43f2-bc65-de59a5ed1aed", "openfda": {"rxcui": ["259176", "1358762", "1359117", "1927957"], "spl_set_id": ["3eb092dc-2ec1-4d55-b1fe-69505608e04a"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (65862-934-58)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-934-58", "marketing_start_date": "20170615"}, {"sample": false, "description": "1 POUCH in 1 CARTON (65862-934-87)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-934-87", "marketing_start_date": "20170615"}, {"sample": false, "description": "3 POUCH in 1 CARTON (65862-934-88)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "65862-934-88", "marketing_start_date": "20170615"}], "brand_name": "Aurovela 24 Fe", "product_id": "65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aed", "dosage_form": "KIT", "product_ndc": "65862-934", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aurovela 24 Fe", "application_number": "ANDA207504", "marketing_category": "ANDA", "marketing_start_date": "20170615", "listing_expiration_date": "20261231"}