FDA.reportPublic FDA data

NDC 68180-893-71 - PIRMELLA 7/7/7

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
68180-893
Requested NDC
68180-893-71
Package NDCs from labels
68180-893-71, 68180-893-73, 68180-893-11, 68180-893-13
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2022-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PIRMELLA 7/7/7 - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2022-12-20HUMAN PRESCRIPTION DRUG LABEL
PIRMELLA 7/7/7 - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2019-10-30HUMAN PRESCRIPTION DRUG LABEL
PIRMELLA 1/35 - Lupin Pharmaceuticals, Inc.Lupin Pharmaceuticals, Inc.2013-12-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-893-11PIRMELLA 1/351 in 1 BLISTER PACKKIT15
68180-893-13PIRMELLA 1/353 in 1 CARTONKIT35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-893PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20140108_bb21b098-284a-4cad-bf8f-a062e88a3d56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-893-11EA - Each68180-8937a82d291-17bf-4937-bcf0-724a994fa56112013-08-02
68180-893-13EA - Each68180-893242e3b42-5dc6-493f-a83b-290abda1491512013-08-02
68180-893-71EA - Each68180-8932003e851-3c98-4ec1-961b-b22fb330b67512019-12-10
68180-893-73EA - Each68180-893fbcf67d8-ba97-471b-9847-c3641e3b2f6d12019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
NORETHINDRONEACTIVE INGREDIENTT18F433X4SPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
NORETHINDRONEACTIVE MOIETYT18F433X4SPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPIRMELLA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT PIRMELLA 1/35 ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
NORETHINDRONEACTIVE INGREDIENTT18F433X4SPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
NORETHINDRONEACTIVE MOIETYT18F433X4SPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPIRMELLA 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]5

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 5 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low-OgestrelNORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.8755b020-d439-4ba2-a60b-6c57a15ece552025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b91ad328-f2f4-4f7d-82d3-daaada95f5092025-07-28Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevoraLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.31679b9f-58c9-4bf1-8c2c-f5a216ff4cd32025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SRONYXLEVONORGESTREL AND ETHINYL ESTRADIOLMayne Pharma Inc.b0c1a495-4cd7-4664-8fe4-714812f53c712025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Cyred EQDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack241fb1e2-c0da-47b8-b502-2cb17976d7c02025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
YazDROSPIRENONE AND ETHINYL ESTRADIOLBayer HealthCare Pharmaceuticals Inc.065f33e4-b587-4e66-b896-ca9ab7b7c8762025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.00dd9b78-dd90-414b-b241-7619aa9d1ed22025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
PortiaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.c78b236b-85c4-4258-a524-cea08775100c2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.843cbef6-cbfb-4a44-bb80-22930753e4c02025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
FalminaLEVONORGESTREL AND ETHINYL ESTRADIOLNorthstar Rx LLCcf6f069e-4b78-4adb-b5be-100b9d85aab72025-02-21Warnings, Adverse reactionsExact identifier
rxcui: 748797
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: T18F433X4S

Reported adverse events (FAERS/openFDA)#

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