abigale lo

Generic: estradiol and norethindrone acetate

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

Drug Facts

Product Profile

Brand Name abigale lo
Generic Name estradiol and norethindrone acetate
Labeler xiromed llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

estradiol .5 mg/1, norethindrone acetate .1 mg/1

Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-303
Product ID 70700-303_35d8f763-8f98-f5ea-fae8-1367b638e82c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207261
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700303
Hyphenated Format 70700-303

Supplemental Identifiers

RxCUI
1359123 1359124 1359126 1359127 2706646 2706647
UNII
9S44LIC7OJ 4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

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 abigale lo (source: ndc)
Generic Name estradiol and norethindrone acetate (source: ndc)
Application Number ANDA207261 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
  • .1 mg/1
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70700-303-85 3 POUCH in 1 CARTON (70700-303-85) / 1 BLISTER PACK in 1 POUCH (70700-303-84) / 28 TABLET in 1 BLISTER PACK

Ingredients (2)

estradiol (.5 mg/1) norethindrone acetate (.1 mg/1)

Linked Drug Pages (1)

ABIGALE LO, ABIGALE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35d8f763-8f98-f5ea-fae8-1367b638e82c", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1359123", "1359124", "1359126", "1359127", "2706646", "2706647"], "spl_set_id": ["df013d36-de10-0607-7e12-95ed43bf7ee9"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70700-303-85)  / 1 BLISTER PACK in 1 POUCH (70700-303-84)  / 28 TABLET in 1 BLISTER PACK", "package_ndc": "70700-303-85", "marketing_start_date": "20250129"}], "brand_name": "ABIGALE LO", "product_id": "70700-303_35d8f763-8f98-f5ea-fae8-1367b638e82c", "dosage_form": "TABLET", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70700-303", "generic_name": "estradiol and norethindrone acetate", "labeler_name": "Xiromed LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ABIGALE LO", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".5 mg/1"}, {"name": "NORETHINDRONE ACETATE", "strength": ".1 mg/1"}], "application_number": "ANDA207261", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}