FDA.reportPublic FDA data

NDC 0378-3340-16 - XULANE

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
0378-3340
Requested NDC
0378-3340-16
Package NDCs from labels
0378-3340-16, 0378-3340-53
Manufacturer
A-S Medication Solutions
Effective date
2024-02-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
XULANE - A-S Medication SolutionsA-S Medication Solutions2024-02-27HUMAN PRESCRIPTION DRUG LABEL
XULANE - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2022-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3340-16XULANE7 d in 1 PATCHPATCH716
0378-3340-16XULANE1 in 1 POUCHPATCH116
0378-3340-17XULANE1 in 1 POUCHPATCH116
0378-3340-17XULANE7 d in 1 PATCHPATCH716
0378-3340-32XULANE1 in 1 CARTONPATCH116
0378-3340-53XULANE3 in 1 CARTONPATCH316

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3340XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]16Current NDC, Legacy NDC, 6 package rows20220505_f7848550-086a-43d8-8ae5-047f4b9e4382.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3340-16EA - Each0378-334029a3b2df-d582-4788-94c0-84f1ce21150712017-06-15
0378-3340-53EA - Each0378-3340fa993b2c-a314-4ad5-96f0-406dec3d5dc212014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
NORELGESTROMINACTIVE INGREDIENTR0TAY3X631XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
NORELGESTROMINACTIVE MOIETYR0TAY3X631XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40XULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVXULANE (NORELGESTROMIN AND ETHINYL ESTRADIOL) PATCH [MYLAN PHARMACEUTICALS INC.]2

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 8 · 157 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
unii: T5L8T28FGP
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
unii: T5L8T28FGP
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSportpharm LLC88e3624d-b8bb-4e65-9250-4c51d2bbed162026-02-03WarningsExact identifier
unii: T5L8T28FGP
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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