FDA.reportPublic FDA data

NDC 70700-855 - INTROVALE

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
70700-855
Manufacturer
Xiromed LLC
Effective date
2024-10-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Levonorgestrel and Ethinyl Estradiol tablets - Xiromed LLCXiromed LLC2024-10-15HUMAN PRESCRIPTION DRUG LABEL

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 14 of 15 · 282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
Reclipsen 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a1e00bc6-7487-4057-9dcc-d0e2327d1d122022-01-04Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-Lo-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ddbeb312-af2b-4d22-ab7c-5ab2f3f8d5cb2021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BalzivaNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.36a282d2-7285-442b-9574-dfce2d9456f12021-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.563297dc-f27b-46e3-83de-bade17473d622021-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LessinaLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a5fd1b3a-019c-4871-95b3-a45bbbd46f822021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.47263647-a9ac-40e4-83c0-d6500fa458cd2021-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a9e08f9b-9862-4c2c-8302-53dc82d851262021-12-15Warnings, Adverse reactionsExact identifier
rxcui: 748797
CyonanzNORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited2bd1b72e-fba5-4275-a02a-ed08a5434a922021-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.992dcc56-90ab-4691-8114-16d47a8b99822021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
unii: 423D2T571U
Option 2LEVONORGESTRELL. Perrigo Company9b9e9352-3e4d-4ec3-96aa-8fd58d82fe962020-07-30WarningsExact identifier
unii: 5W7SIA7YZW
Estradiol Valerate and Estradiol Valerate/DienogestESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTSandoz Inc0c3ac139-af85-4c70-ad3d-981e57d86f022020-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPc1fc22e5-e02d-4dda-a9ac-c592e922c4672020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LPd19ff955-1778-43c7-a111-476d740dc9d92019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AfterPlanLEVONORGESTRELSUN PHARMACEUTICAL INDUSTRIES, INC.c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a2018-10-26WarningsExact identifier
unii: 5W7SIA7YZW
Morning AfterLEVONORGESTRELRapha Pharmaceuticals, Inc.677aa953-3c30-4ce5-e053-2991aa0ab2b22018-03-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELNovel Laboratories, Inc.ac13a073-a33a-45f7-8483-eecc9190195f2017-09-15Exact identifier
unii: 5W7SIA7YZW
Tri FemynorNORGESTIMATE AND ETHINYL ESTRADIOLAmneal Pharmaceuticals NY LLC46bbdf70-2b80-4359-a19b-d94ff99eac982016-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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