HALOETTE

Generic: etonogestrel and ethinyl estradiol

Labeler: Dr. Reddy's Labratories Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive

Drug Facts

Product Profile

Brand Name HALOETTE
Generic Name etonogestrel and ethinyl estradiol
Labeler Dr. Reddy's Labratories Inc.
Dosage Form INSERT, EXTENDED RELEASE
Routes
VAGINAL
Active Ingredients

ETHINYL ESTRADIOL .015 mg/d, ETONOGESTREL .12 mg/d

Identifiers & Regulatory

Product NDC 75907-088
Product ID 75907-088_83794fcf-f01b-c198-a58a-075b76ac8a45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211328
Marketing Start 2024-05-28
Marketing End 2026-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75907088
Hyphenated Format 75907-088

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 HALOETTE (source: ndc)
Generic Name etonogestrel and ethinyl estradiol (source: ndc)
Application Number ANDA211328 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .015 mg/d
  • .12 mg/d
source: ndc
Packaging
  • 3 POUCH in 1 CARTON (75907-088-13) / 21 d in 1 POUCH (75907-088-11)
source: ndc

Packages (1)

75907-088-13 3 POUCH in 1 CARTON (75907-088-13) / 21 d in 1 POUCH (75907-088-11)

Ingredients (2)

ETHINYL ESTRADIOL (.015 mg/d) ETONOGESTREL (.12 mg/d)

Linked Drug Pages (1)

HALOETTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "83794fcf-f01b-c198-a58a-075b76ac8a45", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "304GTH6RNH"], "rxcui": ["1367436", "2622921"], "spl_set_id": ["a4e20e92-42f9-9ce9-f6ee-38734c79d19c"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (75907-088-13)  / 21 d in 1 POUCH (75907-088-11)", "package_ndc": "75907-088-13", "marketing_end_date": "20260228", "marketing_start_date": "20240528"}], "brand_name": "HALOETTE", "product_id": "75907-088_83794fcf-f01b-c198-a58a-075b76ac8a45", "dosage_form": "INSERT, EXTENDED RELEASE", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "75907-088", "generic_name": "etonogestrel and ethinyl estradiol", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HALOETTE", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".015 mg/d"}, {"name": "ETONOGESTREL", "strength": ".12 mg/d"}], "application_number": "ANDA211328", "marketing_category": "ANDA", "marketing_end_date": "20260228", "marketing_start_date": "20240528"}