twirla

Generic: levonorgestrel/ethinyl estradiol

Labeler: agile therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name twirla
Generic Name levonorgestrel/ethinyl estradiol
Labeler agile therapeutics, inc.
Dosage Form PATCH
Routes
TRANSDERMAL
Active Ingredients

ethinyl estradiol 2.3 mg/1, levonorgestrel 2.6 mg/1

Manufacturer
Agile Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 71671-100
Product ID 71671-100_722214f4-2c40-93f5-32ea-a297d82b32d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204017
Listing Expiration 2026-12-31
Marketing Start 2020-09-11

Pharmacologic Class

Established (EPC)
estrogen [epc] progestin [epc] progestin-containing intrauterine system [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
progesterone congeners [cs]
Physiologic Effect
inhibit ovum fertilization [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71671100
Hyphenated Format 71671-100

Supplemental Identifiers

RxCUI
2396242 2396253 2396258 2396259
UNII
423D2T571U 5W7SIA7YZW
NUI
N0000175825 N0000000100 N0000175830 M0447349 N0000175602 N0000175832

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 twirla (source: ndc)
Generic Name levonorgestrel/ethinyl estradiol (source: ndc)
Application Number NDA204017 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 2.3 mg/1
  • 2.6 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11)
  • 3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)
source: ndc

Packages (2)

71671-100-01 1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11) 71671-100-03 3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11)

Ingredients (2)

ethinyl estradiol (2.3 mg/1) levonorgestrel (2.6 mg/1)

Linked Drug Pages (1)

Twirla ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "722214f4-2c40-93f5-32ea-a297d82b32d0", "openfda": {"nui": ["N0000175825", "N0000000100", "N0000175830", "M0447349", "N0000175602", "N0000175832"], "unii": ["423D2T571U", "5W7SIA7YZW"], "rxcui": ["2396242", "2396253", "2396258", "2396259"], "spl_set_id": ["bcaf8db0-1750-425d-b008-255b5e7a9cc6"], "pharm_class_cs": ["Progesterone Congeners [CS]"], "pharm_class_pe": ["Inhibit Ovum Fertilization [PE]"], "pharm_class_epc": ["Estrogen [EPC]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Agile Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (71671-100-01)  / 1 PATCH in 1 POUCH (71671-100-11)", "package_ndc": "71671-100-01", "marketing_start_date": "20200911"}, {"sample": false, "description": "3 POUCH in 1 CARTON (71671-100-03)  / 1 PATCH in 1 POUCH (71671-100-11)", "package_ndc": "71671-100-03", "marketing_start_date": "20200911"}], "brand_name": "Twirla", "product_id": "71671-100_722214f4-2c40-93f5-32ea-a297d82b32d0", "dosage_form": "PATCH", "pharm_class": ["Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Inhibit Ovum Fertilization [PE]", "Progesterone Congeners [CS]", "Progesterone Congeners [CS]", "Progestin [EPC]", "Progestin-containing Intrauterine System [EPC]"], "product_ndc": "71671-100", "generic_name": "levonorgestrel/ethinyl estradiol", "labeler_name": "Agile Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Twirla", "active_ingredients": [{"name": "ETHINYL ESTRADIOL", "strength": "2.3 mg/1"}, {"name": "LEVONORGESTREL", "strength": "2.6 mg/1"}], "application_number": "NDA204017", "marketing_category": "NDA", "marketing_start_date": "20200911", "listing_expiration_date": "20261231"}