FDA.reportPublic FDA data

NDC 65862-941-87 - AUROVELA Fe

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
65862-941
Requested NDC
65862-941-87
Package NDCs from labels
65862-941-87, 65862-941-58, 65862-941-88
Manufacturer
Aurobindo Pharma Limited
Effective date
2023-11-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AUROVELA Fe - Aurobindo Pharma LimitedAurobindo Pharma Limited2023-11-21Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-941-58AUROVELA Fe5 in 1 CARTONKIT512
65862-941-87AUROVELA Fe1 in 1 POUCHKIT112
65862-941-87AUROVELA Fe1 in 1 BLISTER PACKKIT112
65862-941-88AUROVELA Fe1 in 1 POUCHKIT112
65862-941-88AUROVELA Fe3 in 1 CARTONKIT312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-941AUROVELA FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 5 package rows20231123_db3d0229-4581-46c0-82a8-7d022c135826.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-941-87EA - Each65862-941a5456cf0-2c2a-4b7f-8982-d7a8aade1d8212019-07-02
65862-941-88EA - Each65862-941585364de-8e1c-467e-8c00-90ce6c8a7c2c12019-07-02

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 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prenatol-MMULTIVITAMINPureTek Corporation17559a44-94b7-9ca0-e063-6294a90a21232024-05-06Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Microgestin 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.6848575e-39d8-418b-ac38-ca2793f6f3672024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
Microgestin Fe 1/20NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEDr. Reddy's Laboratories Inc.5e622180-cbb0-4466-a810-98b3b9663b592024-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
Microgestin Fe 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEDr. Reddys Laboratories Inc17b4ee33-3ec1-440d-9446-f20c51629c2d2024-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359023
rxcui: 259176
Integra PlusFERROUS FUMARATE AND POLYSACCHRIDE IRON VITAMIN MINERAL COMPLEX SUPPLEMENTU.S. Pharmaceutical Corporation9e5b9309-e835-4863-ab6f-e3018e38fc642024-04-03Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Microgestin Fe 1.5/30NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATEProficient Rx LP03053e47-c9ac-42bd-b4cd-3e911564676a2024-04-01Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359023
rxcui: 259176
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: C151H8M554
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
EtyqaESTRADIOL AND NORETHINDRONE ACETATEAurobindo Pharma Limitedafbc2a33-5eb2-4f01-91e9-07d8050da6ce2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LO LOESTRIN FENORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL AND FERROUS FUMARATEA-S Medication Solutionse2f24e91-4893-40bf-b310-d93db95d24422024-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
CombiPatch (estradiol/norethindrone acetate transdermal system)ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEMNoven Therapeutics, LLC83198ef1-11c4-11e4-9191-0800200c9a662024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Junel Fe 24NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Pharmaceuticals USA, Inc.ffbf48de-0f61-49f9-9cd5-6eb8e08040db2024-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
OSHIHNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited7c07e339-3aae-4c77-a170-e6715bbe75632024-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176

Reported adverse events (FAERS/openFDA)#

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