FDA.reportPublic FDA data

NDC 0555-9014-79 - Lessina

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0555-9014
Requested NDC
0555-9014-79
Package NDCs from labels
0555-9014-79, 0555-9014-67
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2021-12-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lessina - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2021-12-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9014-67Lessina3 in 1 CARTONKIT310
0555-9014-79Lessina1 in 1 POUCHKIT110
0555-9014-79Lessina1 in 1 BLISTER PACKKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9014LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]10Current NDC, Legacy NDC, 3 package rows20211230_a5fd1b3a-019c-4871-95b3-a45bbbd46f82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9014-67EA - Each0555-9014453632d3-b554-4447-a635-db4a1abc38e112013-02-13
0555-9014-79EA - Each0555-901485eaa2fc-5bc9-432b-be1a-12ea91d5d6f012017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBULESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 47 of 120 · 2,390 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
unii: 15FIX9V2JP
Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.7d82aa5d-aee9-4c72-9b9b-af7adad21f4c2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEABOUT FACE AESTHETICS, INC.364728b4-e0ff-8466-e063-6394a90a00892025-12-10Exact identifier
unii: 15FIX9V2JP
tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d42661-e511-1dfc-e063-6294a90a9ed72025-12-10Exact identifier
unii: 15FIX9V2JP
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
unii: 15FIX9V2JP
Smoothing Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION32721b87-aef1-d759-e063-6394a90a40d32025-12-10Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral StickTITANIUM DIOXIDE, ZINC OXIDEShelley Bennett Skincare326e9a14-5fb6-6a6e-e063-6294a90adece2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bafa0b-d253-c263-e063-6394a90ad1e42025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35ba578f-a842-7eec-e063-6394a90a11652025-12-10Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bc3994-1f72-2bbf-e063-6294a90ac2f12025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bccadf-6fc8-abd0-e063-6294a90aaa2e2025-12-10Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
unii: 15FIX9V2JP
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
unii: 15FIX9V2JP
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.