galbriela

Generic: norethindrone and ethinyl estradiol and ferrous fumarate

Labeler: xiromed, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galbriela
Generic Name norethindrone and ethinyl estradiol and ferrous fumarate
Labeler xiromed, llc
Dosage Form KIT
Manufacturer
Xiromed, LLC

Identifiers & Regulatory

Product NDC 70700-306
Product ID 70700-306_8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203371
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700306
Hyphenated Format 70700-306

Supplemental Identifiers

RxCUI
1095223 1099638 1607990 2704559
UPC
0370700306857

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 galbriela (source: ndc)
Generic Name norethindrone and ethinyl estradiol and ferrous fumarate (source: ndc)
Application Number ANDA203371 (source: ndc)

Resolved Composition

Strengths
  • 0.8 mg
  • 0.025 mg
  • 75 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

70700-306-85 3 POUCH in 1 CARTON (70700-306-85) / 1 BLISTER PACK in 1 POUCH (70700-306-84) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

GALBRIELA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5", "openfda": {"upc": ["0370700306857"], "rxcui": ["1095223", "1099638", "1607990", "2704559"], "spl_set_id": ["47465e7e-64f2-690b-166e-0e1c3e5bec7a"], "manufacturer_name": ["Xiromed, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70700-306-85)  / 1 BLISTER PACK in 1 POUCH (70700-306-84)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "70700-306-85", "marketing_start_date": "20250129"}], "brand_name": "GALBRIELA", "product_id": "70700-306_8bfd4743-1a58-fcc9-de5c-6eb5ad6a0bc5", "dosage_form": "KIT", "product_ndc": "70700-306", "generic_name": "norethindrone and ethinyl estradiol and ferrous fumarate", "labeler_name": "Xiromed, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GALBRIELA", "application_number": "ANDA203371", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}