FDA.reportPublic FDA data

NDC 68180-913 - DROSPIRENONE AND ETHINYL ESTRADIOL

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
68180-913
Package NDCs from labels
68180-913-74
Manufacturer
Redpharm Drug
Effective date
2026-07-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DROSPIRENONE AND ETHINYL ESTRADIOL - Redpharm DrugRedpharm Drug2026-07-30HUMAN PRESCRIPTION DRUG LABEL
DROSPIRENONE AND ETHINYL ESTRADIOL - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-913DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]6Unmatched20250223_a8955f3b-afc9-4ef0-8946-9c97ab5b2e05.zip

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 107 of 112 · 2,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nylia 1/35NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb31bd776-3926-4b77-aa29-f5a8eef611aa2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LEVONORGESTREL AND ETHINYL ESTRADIOLLEVONORGESTREL AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.c3c00dc0-8834-45fb-9f5b-810a98cef59d2022-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nortrel 7/7/7 (28 Day Regimen)NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LP5b684f8f-9610-4449-a213-f70bb4a04b8b2022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
CryselleNORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.ee6be128-d494-4361-9a0d-341c0eee35872022-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLProficient Rx LP151048e4-849c-4a66-bf18-c0351e8eefeb2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Nylia 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLAurobindo Pharma Limited867c5630-51be-4469-bf79-6a5cd4302cfa2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
IntrovaleLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.f5bc2427-3a18-e3e6-a058-210688e9c4462022-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4e1927bd-378d-45dc-8b18-3dd57ccd2cb62022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
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
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

Reported adverse events (FAERS/openFDA)#

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