FDA.reportPublic FDA data

NDC 68180-892-71 - 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
68180-892
Requested NDC
68180-892-71
Package NDCs from labels
68180-892-71, 68180-892-73, 68180-892-11, 68180-892-13
Manufacturer
A-S Medication Solutions
Effective date
2023-02-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PIRMELLA 7/7/7 - A-S Medication SolutionsA-S Medication Solutions2023-02-22HUMAN PRESCRIPTION DRUG LABEL
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 7/7/7 - Central Texas Community Health Centers | LUPIN LIMITEDCentral Texas Community Health Centers | LUPIN LIMITED2017-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-892-11EA - Each68180-892f8918832-e757-4e99-ad60-09b424f3021012013-07-02
68180-892-13EA - Each68180-89273b137fd-ca9c-424d-95ce-8d943fa06aea12013-07-02
68180-892-71EA - Each68180-892dd770b07-34e5-4ea9-9aa9-d969a179562512020-01-03
68180-892-73EA - Each68180-892ba094228-f68f-4688-932d-b57229946a8f12020-01-03

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

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 8 of 12 · 239 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone and ethinyl estradiolNORETHINDRONE AND ETHINYL ESTRADIOLNaari Pte Limited9bd9119e-a874-41e2-ac58-b7f0d155d2fb2024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 312033
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLNaari Pte. Limitedd96f0dd8-4eb9-42f7-ab5e-b5515dcf73d62024-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
desogestrel and ethinyl estradiol and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLNaari Pte. Limitedf8961550-d103-8ee6-e053-6294a90a75712024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748797
NeconNORETHINDRONE AND ETHINYL ESTRADIOLDr. Reddy's Laboratories Inc.1ca12bf6-9583-4578-8411-51ad02a405ec2024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 310463
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
KarivaDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.7b11e11f-6977-4109-b9bd-a066e5d1278a2024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions4d888008-cc14-4291-b384-0d482f48eb082024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsExact identifier
unii: T18F433X4S
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Tri-VyLibraNORGESTIMATE AND ETHINYL ESTRADIOLAfaxys Pharma, LLCf59acc3e-21d9-4fa3-ad52-d77225739e1a2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VolneaDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack0e65209d-329a-4d31-8afb-24348dc8d7e72024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3c0c983-7ec7-244a-e053-2995a90adbe42024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3ce752d-58df-363d-e053-2a95a90a54112024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLAvKAREa3cfd79e-a344-1dfc-e053-2995a90a1ab72024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SyedaDROSPIRENONE AND ETHINYL ESTRADIOLBryant Ranch Prepack4424505f-acae-43ba-8a75-eadd0e283b232024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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