FDA.reportPublic FDA data

LEVONORGESTREL

Substance profile for UNII 5W7SIA7YZW, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for LEVONORGESTREL
Structure render from PubChem CID 13109

Substance Identity#

UNII
5W7SIA7YZW
Preferred term
LEVONORGESTREL
Registry number
797-63-7
EC number
212-349-8
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C21H28O2
Chemical structure for LEVONORGESTREL
Structure render from PubChem CID 13109

Chemical And Database Identifiers#

InChIKey
WWYNJERNGUHSAO-XUDSTZEESA-N
SMILES
CC[C@]12CC[C@H]3[C@@H](CCC4=CC(=O)CC[C@H]34)[C@@H]1CC[C@@]2(O)C#C
RxCUI
6373
PubChem
13109
NCIt
C47585
INN ID
3475

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound13109pubchem.ncbi.nlm.nih.gov/compound/13109
PubChem InChIKey SearchWWYNJERNGUHSAO-XUDSTZEESA-Npubchem.ncbi.nlm.nih.gov/#query=WWYNJERNGUHSAO-XUDSTZEESA-N
RxNorm6373mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=6373
NCI ThesaurusC47585ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47585
FDA Substance Registration System5W7SIA7YZWprecision.fda.gov/uniisearch/srs/unii/5W7SIA7YZW
European Community number212-349-8commonchemistry.cas.org/results?q=212-349-8

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE INGREDIENTFalessa Kit5
ACTIVE MOIETYFalessa Kit5
ACTIVE INGREDIENTDrug Facts1
ACTIVE MOIETYDrug Facts1
ACTIVE MOIETYDELYLA™ (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Rx only1
ACTIVE INGREDIENTDELYLA™ (Levonorgestrel and Ethinyl Estradiol Tablets, USP) Rx only1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use My Way safely and effectively. See full prescribing information for My Way. My Way (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19821
ACTIVE INGREDIENTThese highlights do not include all the information needed to use My Way safely and effectively. See full prescribing information for My Way. My Way (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19821
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19822
ACTIVE MOIETYThese highlights do not include all the information needed to use Levonorgestrel safely and effectively. See full prescribing information for Levonorgestrel. Levonorgestrel (Levonorgestrel) TABLET for ORAL use. Initial U.S. Approval: 19822
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Next Choice TM safely and effectively. See full prescribing information for Next Choice TM . Next Choice TM (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use Next Choice TM safely and effectively. See full prescribing information for Next Choice TM . Next Choice TM (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYWATSON PHARMA Revised: May 2005 IN-5262/S PHYSICIAN LABELING Levora ® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) Rx only1
ACTIVE INGREDIENTWATSON PHARMA Revised: May 2005 IN-5262/S PHYSICIAN LABELING Levora ® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) Rx only1
ACTIVE MOIETYWATSON PHARMA Revised: May 2005 IN-5262/S PHYSICIAN LABELING Levora ® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) Rx only1
ACTIVE INGREDIENTWATSON PHARMA Revised: May 2005 IN-5262/S PHYSICIAN LABELING Levora ® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) Rx only1
ACTIVE MOIETYWATSONPHARMA Revised: April 2007 IN-5351/S Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP) Rx only1
ACTIVE INGREDIENTWATSONPHARMA Revised: April 2007 IN-5351/S Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP) Rx only1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Plan B safely and effectively. See full prescribing information for Plan B. Plan B (levonorgestrel) tablets, 0.75mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use Plan B safely and effectively. See full prescribing information for Plan B. Plan B (levonorgestrel) tablets, 0.75mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use LoSeasonique tablets safely and effectively. See full prescribing information for LoSeasonique. LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 19822
ACTIVE INGREDIENTThese highlights do not include all the information needed to use LoSeasonique tablets safely and effectively. See full prescribing information for LoSeasonique. LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 19822
ACTIVE MOIETYAviane ® - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP)1
ACTIVE INGREDIENTAviane ® - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP)1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Next Choice TM safely and effectively. See full prescribing information for Next Choice TM . Next Choice TM (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use Next Choice TM safely and effectively. See full prescribing information for Next Choice TM . Next Choice TM (levonorgestrel) Tablets, 0.75 mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYRevised: November 2007 IN-5427/S PHYSICIAN LABELING Trivora ® (levonorgestrel and ethinyl estradiol tablets USP) triphasic regimen Rx only1
ACTIVE INGREDIENTRevised: November 2007 IN-5427/S PHYSICIAN LABELING Trivora ® (levonorgestrel and ethinyl estradiol tablets USP) triphasic regimen Rx only1
ACTIVE MOIETYThese highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 19821
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Plan B One-Step safely and effectively. See full prescribing information for Plan B One-Step. Plan B One-Step (levonorgestrel) tablet, 1.5 mg, for oral use Initial U.S. Approval: 19821
ACTIVE MOIETY709031e4-4c20-4ea7-beff-6c459709a4331
ACTIVE INGREDIENT709031e4-4c20-4ea7-beff-6c459709a4331
ACTIVE MOIETYENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)1
ACTIVE INGREDIENTENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)1
ACTIVE MOIETYENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)1
ACTIVE INGREDIENTENPRESSE™ – 28 TABLETS (levonorgestrel and ethinyl estradiol tablets, USP – triphasic regimen)1
ACTIVE INGREDIENTThese highlights do not include all the information needed to use Seasonique safely and effectively. See full prescribing information for Seasonique. Seasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 19821
ACTIVE MOIETYThese highlights do not include all the information needed to use Seasonique safely and effectively. See full prescribing information for Seasonique. Seasonique (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) for oral use Initial U.S. Approval: 19821
ACTIVE INGREDIENTAviane ® - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP)1
ACTIVE MOIETYAviane ® - 28 DAY (levonorgestrel and ethinyl estradiol tablets, USP)1
ACTIVE MOIETYLevonorgestrel Tablets, 0.75 mg1
ACTIVE INGREDIENTLevonorgestrel Tablets, 0.75 mg1
ACTIVE MOIETYClimara Pro1
ACTIVE INGREDIENTClimara Pro1
ACTIVE INGREDIENTMYZILRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]14
ACTIVE MOIETYMYZILRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]14
ACTIVE MOIETYLEVONORGESTREL (NEXT CHOICE ONE DOSE) TABLET [WATSON PHARMA, INC.]11
ACTIVE INGREDIENTLEVONORGESTREL (NEXT CHOICE ONE DOSE) TABLET [WATSON PHARMA, INC.]11
ACTIVE INGREDIENTMIRENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]10
ACTIVE MOIETYMIRENA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]10
ACTIVE INGREDIENTLEVORA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]9
ACTIVE MOIETYLEVORA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]9
ACTIVE INGREDIENTORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
ACTIVE MOIETYORSYTHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]9
ACTIVE INGREDIENTAMETHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]8
ACTIVE MOIETYAMETHIA (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]8
ACTIVE INGREDIENTQUASENSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]8
ACTIVE MOIETYQUASENSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]8
ACTIVE MOIETYCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ACTIVE INGREDIENTCLIMARA PRO (ESTRADIOL AND LEVONORGESTREL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ACTIVE MOIETYSEASONIQUE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH]7
ACTIVE INGREDIENTSEASONIQUE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH]7
ACTIVE MOIETYSKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ACTIVE INGREDIENTSKYLA (LEVONORGESTREL) INTRAUTERINE DEVICE [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ACTIVE MOIETYCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
ACTIVE INGREDIENTCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ACTIVE INGREDIENTMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
ACTIVE MOIETYMARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]6
ACTIVE MOIETYPLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]6
ACTIVE INGREDIENTPLAN B ONE-STEP (LEVONORGESTREL) TABLET [TEVA WOMEN'S HEALTH, INC.]6
ACTIVE MOIETYCAMRESELO (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA INC]5
ACTIVE INGREDIENTCAMRESELO (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA INC]5
ACTIVE MOIETYDAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
ACTIVE INGREDIENTDAYSEE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
ACTIVE MOIETYJOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ACTIVE INGREDIENTJOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]5
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MYLAN PHARMACEUTICALS INC.]5
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ) KIT [MYLAN PHARMACEUTICALS INC.]5
ACTIVE INGREDIENTLEVONORGESTREL EMERGENCY CONTRACEPTIVE (LEVONORGESTREL) TABLET [PERRIGO NEW YORK INC]5
ACTIVE MOIETYLEVONORGESTREL EMERGENCY CONTRACEPTIVE (LEVONORGESTREL) TABLET [PERRIGO NEW YORK INC]5
ACTIVE MOIETYLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
ACTIVE INGREDIENTLOSEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA WOMEN'S HEALTH, INC.]5
ACTIVE INGREDIENTSRONYX (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]5
ACTIVE MOIETYSRONYX (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]5
ACTIVE MOIETYTRIVORA (LEVONOGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]5
ACTIVE INGREDIENTTRIVORA (LEVONOGESTREL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]5
ACTIVE MOIETYAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ACTIVE INGREDIENTAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ACTIVE INGREDIENTKURVELO ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]4
ACTIVE MOIETYKURVELO ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]4
ACTIVE INGREDIENTLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ACTIVE MOIETYLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ACTIVE INGREDIENTLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]4
ACTIVE MOIETYLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]4
ACTIVE INGREDIENTNEXT CHOICE (LEVONORGESTREL) TABLET [WATSON PHARMA, INC.]4
ACTIVE MOIETYNEXT CHOICE (LEVONORGESTREL) TABLET [WATSON PHARMA, INC.]4
ACTIVE INGREDIENTPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ACTIVE MOIETYPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ACTIVE INGREDIENTVIENVA TM (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [SANDOZ INC]4
ACTIVE MOIETYVIENVA TM (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [SANDOZ INC]4
ACTIVE INGREDIENTAMETHIA LO (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]3
ACTIVE MOIETYAMETHIA LO (LEVONORGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [WATSON PHARMA, INC.]3
ACTIVE MOIETYAMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.]3
ACTIVE INGREDIENTAMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.]3
ACTIVE INGREDIENTAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ACTIVE MOIETYAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ACTIVE INGREDIENTCAMRESE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA INC]3
ACTIVE MOIETYCAMRESE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA INC]3
ACTIVE MOIETYENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ACTIVE INGREDIENTENPRESSE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3