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 7 of 12 · 238 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 748797
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSDr. Reddys Laboratories Inc.fb636d42-cc1d-47f7-974d-c97c79207f3e2024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo- EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack90f7ab24-7839-4408-9a74-07bb6a79eacc2024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepack6560d15f-6ce9-4f0e-9b59-043dec35ddd92024-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedea9f7216-0358-43a9-96eb-5dad694ae9b82024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JasmielDROSPIRENONE AND ETHINYL ESTRADIOLAfaxys Pharma, LLC1a3211f8-41f5-4905-a466-0d79add5fdad2024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutionsa45ee86e-69ca-49a5-8990-5dde52d4a5222024-05-07Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749858
rxcui: 312033
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions33b895e4-b467-41b1-a812-8068cc5bb93e2024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions9b1f944b-b05b-4ab0-bcf6-42f426b07c452024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf4f8ea-1eb3-4a43-87d2-16f93e9044432024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limitedb936a6fb-27ed-44de-9199-8c656bcd366e2024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLNaari Pte Limited03de435b-b8fb-4faa-a0ec-01e48b5aaae42024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf0323be5-9654-4236-8164-230f51a028cd2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsExact identifier
unii: T18F433X4S

Reported adverse events (FAERS/openFDA)#

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