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 9 of 12 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.34b2924f-d220-4344-8cdd-e7dda54061c22024-02-02WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.768502e2-541f-4de8-ac68-3ab47c1f436d2024-02-01WarningsExact identifier
unii: H4N855PNZ1
FlorivaVITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, AND SODIUM FLUORIDEBonGeo Pharmaceuticals, Inc.3d5fbe3a-a95b-4688-a96e-b34e6e1e868a2024-02-01WarningsExact identifier
unii: H4N855PNZ1
PNV-SelectVITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAcella Pharmaceuticals, LLC9f4ce551-7a80-4ddb-a014-95c44b54a4202024-01-16Boxed warning, Adverse reactionsExact identifier
unii: R5L488RY0Q
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
unii: 423D2T571U
unii: 9S44LIC7OJ
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
unii: 9S44LIC7OJ
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEA-S Medication Solutions421b8cf7-119f-495a-b10a-bd864e87ab5a2023-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Norethindrone acetateNORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC2f39b608-cc62-4ff0-a52a-bc33432752692023-12-04Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
unii: 423D2T571U
unii: 9S44LIC7OJ
Aurovela Fe 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited83513d13-5352-4d86-9dfd-fd1e456087c02023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 259176
Tarina Fe 1/20 EQNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAfaxys Pharma, LLCed7dd100-a339-41bc-91be-6d20b73dbce62023-11-21Warnings, Adverse reactionsExact identifier
rxcui: 259176
AUROVELA FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limiteddb3d0229-4581-46c0-82a8-7d022c1358262023-11-21Warnings, Adverse reactionsExact identifier
application number: ANDA207580
ndc (package): 65862-941-58
ndc (package): 65862-941-87
ndc (package): 65862-941-88
ndc (product): 65862-941
ndc11 (package): 65862094187
rxcui: 1359022
rxcui: 1359023
rxcui: 1986791
rxcui: 259176
spl id: 837c477f-da74-4754-90a5-a33af31a6fea
spl set id: db3d0229-4581-46c0-82a8-7d022c135826
Aurovela 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAurobindo Pharma Limited3eb092dc-2ec1-4d55-b1fe-69505608e04a2023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 259176
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 9S44LIC7OJ
Pain FormulaSALIX ALBA, ASCORBICUM ACIDUM, VITAMIN A, VITAMIN E, ACETYLSALICYLICUM ACIDUMNutritional Specialties, Inc.0cc0d205-83c2-4205-a93c-6a8ba55956d42023-11-20WarningsExact identifier
unii: H4N855PNZ1

Reported adverse events (FAERS/openFDA)#

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