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 2 of 121 · 2,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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