FDA.reportPublic FDA data

NDC 70700-208-87 - 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
70700-208
Requested NDC
70700-208-87
Package NDCs from labels
70700-208-87, 70700-208-88
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-208-87INTROVALE1 in 1 POUCHKIT11
70700-208-87INTROVALE1 in 1 BLISTER PACKKIT11
70700-208-88INTROVALE3 in 1 CARTONKIT31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-208INTROVALE (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS) KIT [XIROMED LLC]1Current NDC, 3 package rows20250305_24abb5e1-5be4-87e7-404c-d8c2db25ffd0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-208-87EA - Each70700-208dd1c3147-8c78-4d12-8dcf-330693636f2312025-08-11
70700-208-88EA - Each70700-208e337d6ae-96a5-42be-a92e-ac93c99a516712025-08-11

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 15 · 282 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
My ChoiceLEVONORGESTRELOHM LABORATORIES INC500d9418-69a8-f4f3-e063-6394a90a9b662026-04-22WarningsExact identifier
unii: 5W7SIA7YZW
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
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
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
VesturaDROSPIRENONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd52026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTRELLEVONORGESTRELCamber Consumer Care Inc2e22d0c4-b308-4a02-b2b0-2c06fb91d1e52026-03-23WarningsExact identifier
unii: 5W7SIA7YZW
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
SkylaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.9f44ff35-e052-49cd-a1c2-0bfd87d493092026-03-04Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf73ece43-6b5f-4abb-ba6d-4d62775f2f8e2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions6edead7f-a41f-4d0b-a27a-b2047ed4eea02026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
RestartLEVONORGESTRELWinx Health Inc.0cdf198e-c114-b9fa-e063-6294a90a566a2026-02-24WarningsExact identifier
unii: 5W7SIA7YZW
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.47fc432b-2259-47d2-bba9-5e3aae5839902026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LevonorgestrelLEVONORGESTRELYYBA Corp49008f10-8a70-3c08-e063-6294a90a44a32026-02-03WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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