etonogestrel/ethinyl estradiol

Generic: etonogestrel and ethinyl estradiol

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name etonogestrel/ethinyl estradiol
Generic Name etonogestrel and ethinyl estradiol
Labeler prasco laboratories
Dosage Form INSERT, EXTENDED RELEASE
Routes
VAGINAL
Active Ingredients

ethinyl estradiol .015 mg/d, etonogestrel .12 mg/d

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-605
Product ID 66993-605_180f8196-0a6d-4f41-9838-e84a84a2bd19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021187
Listing Expiration 2026-12-31
Marketing Start 2021-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993605
Hyphenated Format 66993-605

Supplemental Identifiers

RxCUI
1367436
UNII
423D2T571U 304GTH6RNH
NUI
N0000175825 N0000000100 M0447349 N0000175602

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 etonogestrel/ethinyl estradiol (source: ndc)
Generic Name etonogestrel and ethinyl estradiol (source: ndc)
Application Number NDA021187 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • .015 mg/d
  • .12 mg/d
source: ndc
Packaging
  • 3 POUCH in 1 BOX (66993-605-36) / 21 d in 1 POUCH (66993-605-81)
source: ndc

Packages (1)

66993-605-36 3 POUCH in 1 BOX (66993-605-36) / 21 d in 1 POUCH (66993-605-81)

Ingredients (2)

ethinyl estradiol (.015 mg/d) etonogestrel (.12 mg/d)

Linked Drug Pages (1)

Etonogestrel/Ethinyl Estradiol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "180f8196-0a6d-4f41-9838-e84a84a2bd19", "openfda": {"nui": ["N0000175825", "N0000000100", "M0447349", "N0000175602"], "unii": ["423D2T571U", "304GTH6RNH"], "rxcui": ["1367436"], "spl_set_id": ["f0d80e01-f4f5-4b1a-bc9e-50a2bd4390b1"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 BOX (66993-605-36)  / 21 d in 1 POUCH (66993-605-81)", "package_ndc": "66993-605-36", "marketing_start_date": "20210601"}], "brand_name": "Etonogestrel/Ethinyl Estradiol", "product_id": "66993-605_180f8196-0a6d-4f41-9838-e84a84a2bd19", "dosage_form": "INSERT, EXTENDED RELEASE", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "66993-605", "generic_name": "etonogestrel and ethinyl estradiol", "labeler_name": "Prasco Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etonogestrel/Ethinyl Estradiol", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": ".015 mg/d"}, {"name": "ETONOGESTREL", "strength": ".12 mg/d"}], "application_number": "NDA021187", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20210601", "listing_expiration_date": "20261231"}