FDA.reportPublic FDA data

NDC 0555-9020-79 - Portia

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
0555-9020
Requested NDC
0555-9020-79
Package NDCs from labels
0555-9020-79, 0555-9020-58
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2025-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Portia ® (levonorgestrel and ethinyl estradiol tablets USP) Rx onlyTeva Pharmaceuticals USA, Inc.2025-03-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9020-58Portia6 in 1 CARTONKIT615
0555-9020-79Portia1 in 1 POUCHKIT115
0555-9020-79Portia1 in 1 BLISTER PACKKIT115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9020PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20250410_c78b236b-85c4-4258-a524-cea08775100c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9020-58EA - Each0555-90200363de16-7821-4c79-93a8-e57d40cfa14c12013-02-13
0555-9020-79EA - Each0555-9020c7979e85-926c-4101-97e7-5a05c17697cf12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPORTIA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPORTIA (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 1 of 122 · 2,430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 238019
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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