FDA.reportPublic FDA data

NDC 0781-4024 - 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
0781-4024
Package NDCs from labels
0781-4024-72
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4024OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]34Unmatched20241215_58d84ffa-4056-4e36-ad67-7bd4aef444a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOMATROPINACTIVE INGREDIENTNQX9KB6PCLOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SOMATROPINACTIVE MOIETYNQX9KB6PCLOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
GLYCINEINACTIVE INGREDIENTTE7660XO1COMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
PHENOLINACTIVE INGREDIENT339NCG44TVOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BOMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK665956OMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24
WATERINACTIVE INGREDIENT059QF0KO0ROMNITROPE (SOMATROPIN) INJECTION, SOLUTION OMNITROPE (SOMATROPIN) KIT [SANDOZ INC]24

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 2 of 20 · 397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
unii: 339NCG44TV
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: 339NCG44TV

Reported adverse events (FAERS/openFDA)#

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