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 11 of 12 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venexa FEFERROUS FUMARATE, FOLIC ACIDPureTek Corporationba142128-21c4-4204-e053-2a95a90ae0d72023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Ribotin-EFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfcd-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Ventrixyl FeFERROUS FUMARATE, FOLIC ACIDPureTek Corporationc7a626ec-88ec-d899-e053-2a95a90ab0ba2023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Zintrexyl-CFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb1492c5-bfca-d632-e053-2a95a90ad7d12023-01-11Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
Junel Fe 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEProficient Rx LP253c6b2e-2c93-4ee7-94a6-fd063c569c1f2022-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359022
rxcui: 1359023
rxcui: 259176
Norethindrone AcetateNORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.f73f9807-4af6-4faa-ba9a-656a47a4c5e02022-11-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Telomere - DNACA98, CAROTENOID, DNA, GLUTATHIONE, OMEGA 3, PITUITARUM, RNA, VITAMIN B COMPLEX, VITAMIN C, VITAMIN D3, VITAMIN EProBLENb093dfba-ed48-47a2-b4ce-f706221935a12022-11-30WarningsExact identifier
unii: H4N855PNZ1
Immune SupportARSENICUM ALBUM, RUMEX, SQUILLA MARITIMA, BRYONIA ALBA, KALI CARBONICUM, GLUTATHIONE, VITAMIN C, VITAMIN C, ZINC PICOLINATE, VITAMIN B, VITAMIN E, BETA GLUCAN, CURCUMIN, GRAPEFRUIT SEED, OREGANO LEAF, GARLIC BULB, OLIVE LEAF, APPLE CIDER VINEGAR, ASTRAGALUS ROOT, MAITAKE MUSHROOM, CATS CLAW BARKProBLENe6f26cf4-dc3d-4d31-aa3e-145167b6ba2b2022-11-30WarningsExact identifier
unii: H4N855PNZ1
Integra FFERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACIDU.S. Pharmaceutical Corporation025fee85-53a8-4161-a806-44fd95d0ca742022-11-08Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Concept DHAVITAMIN- MINERAL OMEGA-3 SUPPLEMENTU.S. Pharmaceutical Corporationbd2051f7-b887-46f6-8d4a-b099fcd086292022-11-08WarningsExact identifier
unii: R5L488RY0Q
Concept OBVITAMIN MINERAL SUPPLEMENTU.S. Pharmaceutical Corporation37992a25-68bd-4050-b936-596ddedc25a32022-11-08Warnings, Adverse reactionsExact identifier
unii: R5L488RY0Q
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
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
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDPatrin Pharma, Inc.59c5c1a4-3f42-441a-b842-903f9bab346f2022-01-13Boxed warningExact identifier
unii: R5L488RY0Q
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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