NDC 0781-4014 - Omnitrope

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
0781-4014
Package NDCs from labels
0781-4014-71
Manufacturer
Sandoz Inc
Effective date
2025-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Omnitrope - Sandoz IncSandoz Inc2025-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-4014-71Omnitrope1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1 mL5.8 mg in 1mL36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4014OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]34Unmatched20241215_58d84ffa-4056-4e36-ad67-7bd4aef444a5.zip

DailyMed Socrata Ingredients#

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 15 of 20 · 397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 339NCG44TV
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
unii: 3980JIH2SW
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
unii: 339NCG44TV
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Monobasic Sodium Phosphate and Dibasic Sodium PhosphateMONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATELupin Pharmaceuticals,Inc.e2fcc382-6fac-4438-ad02-ebc8528dd59a2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
unii: 339NCG44TV
A11 ENVIRO-PROTECTALLIUM SATIVUM, ALTERNARIA ALTERNATA, ASCORBICUM ACIDUM, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, BERBERIS VULGARIS, CADMIUM METALLICUM, CARBONEUM OXYGENISATUM, CHELIDONIUM MAJUS, CHLORINUM, CLADOSPORIUM PHAEROSPERMUM, COCHLIOBOLUS SATIVUS, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, HOUSE DUST, LEAD, LYCOPODIUM CLAVATUM, MALUS SYLVESTRIS, MUCOR PLUMBEUS, NIACIN, PENICILLIUM NOTATUM, PETROLATUM, PHENOL, QUERCUS ROBUR, RHIZOPUS STOLONIFER, SOLIDAGO VIRGAUREA, TABACUM, VITAMIN A, VITAMIN EApex Energetics Inc.bf8f4f21-832c-5258-e053-2995a90a68312024-01-08WarningsExact identifier
unii: 339NCG44TV
D03 LVR-DRNBERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, PHENOL, MILK THISTLE, CHELIDONIUM MAJUS, JUNIPER BERRY, LYCOPODIUM CLAVATUM SPORE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, LACTIC ACID, L-, TARAXACUM OFFICINALE, VISCUM ALBUM FRUITING TOP, AND YUCCA FILAMENTOSAApex Energetics Inc.f7eba30d-04f6-43b6-9020-052f1207e9f22024-01-08WarningsExact identifier
unii: 339NCG44TV
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R
N02 PETROCHEMACETONE, ANILINUM, BENZINUM, BENZOPYRENE, CARBO VEGETABILIS, CARBOLICUM ACIDUM, CARBON TETRACHLORIDE, ETHER, MAGNESIA SULPHURICA, METHYL ALCOHOL, PETROLEUM, PHENOLPHTHALEIN, PHOSPHORUS, PICRICUM ACIDUM, PINE TAR, PLUMBOUS CHLORIDE, PLUMBUM METALLICUM, SULPHONALUM, SULPHURICUM ACIDUM, TEREBINTHINA, TRICHLOROETHYLENE, VANADIUM METALLICUMApex Energetics Inc.ba5e7801-667b-ab7c-e053-2995a90a788c2024-01-08WarningsExact identifier
unii: 339NCG44TV
N03 EXCHEMALLIUM SATIVUM, ARSENICUM ALBUM, BENZOICUM ACIDUM, BERBERIS VULGARIS, BETULA VERRUCOSA, CALCAREA CARBONICA, CARBOLICUM ACIDUM, CHELIDONIUM MAJUS, CHLORINUM, CITRICUM ACIDUM, HISTAMINUM, ICHTHYOLUM, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM BICARBONICUM, SODIUM HYPOCHLORITE, SOLIDAGO VIRGAUREA, SULPHURApex Energetics Inc.ba73a050-9a5d-1549-e053-2a95a90a62aa2024-01-08WarningsExact identifier
unii: 339NCG44TV
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
unii: 059QF0KO0R
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
unii: 339NCG44TV
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Antiseptic Instant Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharma Nobis, LLCe42f484d-a642-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
unii: 339NCG44TV
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
unii: 339NCG44TV

Reported adverse events (FAERS/openFDA)#

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