norethindrone acetate and ethinyl estradiol and ferrous fumarate

Generic: norethindrone acetate and ethinyl estradiol and ferrous fumarate

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

Drug Facts

Product Profile

Brand Name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form KIT
Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-849
Product ID 68462-849_920756d5-a617-404c-968d-ccf58740fa1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213418
Listing Expiration 2027-12-31
Marketing Start 2022-07-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462849
Hyphenated Format 68462-849

Supplemental Identifiers

RxCUI
1421459 1421460 1421461
UPC
0368462849842

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 norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Generic Name norethindrone acetate and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA213418 (source: ndc)

Resolved Composition

Strengths
  • 1 mg
  • 20 mcg
  • 75 mg
source: label
Packaging
  • 3 CARTON in 1 BOX (68462-849-29) / 1 BLISTER PACK in 1 CARTON (68462-849-84) / 1 KIT in 1 BLISTER PACK * 24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40) * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)
source: ndc

Packages (1)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"spl_id": "920756d5-a617-404c-968d-ccf58740fa1e", "openfda": {"upc": ["0368462849842"], "rxcui": ["1421459", "1421460", "1421461"], "spl_set_id": ["3e608414-5e64-4c69-a9e0-365904cf7df8"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 CARTON in 1 BOX (68462-849-29)  / 1 BLISTER PACK in 1 CARTON (68462-849-84)  / 1 KIT in 1 BLISTER PACK *  24 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-821-40)  *  4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68462-822-40)", "package_ndc": "68462-849-29", "marketing_start_date": "20220727"}], "brand_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "product_id": "68462-849_920756d5-a617-404c-968d-ccf58740fa1e", "dosage_form": "KIT", "product_ndc": "68462-849", "generic_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate", "application_number": "ANDA213418", "marketing_category": "ANDA", "marketing_start_date": "20220727", "listing_expiration_date": "20271231"}