FDA.reportPublic FDA data

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#

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 7 of 20 · 397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
unii: 339NCG44TV
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aminosyn IIISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N-ACETYLTYROSINE, AND GLYCINEICU Medical Inc.5b426208-f090-4650-86c3-89040ba45c2d2025-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Castellani PaintPHENOLStratus Pharamceuticals74192c0e-3c73-4ab0-96d1-1917cbd6777a2025-10-30WarningsExact identifier
unii: 339NCG44TV
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PUBLIX Sore Throat Fast Relief Oral AnestheticPHENOLPUBLIX SUPER MARKETS, INC89291f12-bbc3-4472-8ad3-a34485af72c92025-10-28WarningsExact identifier
unii: 339NCG44TV
PUBLIX Sore Throat Menthol FlavorPHENOLPUBLIX SUPER MARKETS, INC9296c49e-557c-43ed-9527-fcba5093a8dc2025-10-28WarningsExact identifier
unii: 339NCG44TV
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rugby Cherry FlavorPHENOLRUGBY LABORATORIES3d668c78-8130-45d4-bcb7-dddcb2fbe7a32025-10-25WarningsExact identifier
unii: 339NCG44TV
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Diabetic Tussin Sore Throat CherryPHENOLMEDTECH PRODUCTS INCab351229-5771-4c6c-92a8-721cc41c002f2025-10-23WarningsExact identifier
unii: 339NCG44TV
Chloraseptic Childrens Sore Throat CherryPHENOLPrestige Brands Holdings, Inc.38ff6922-1abe-4fa9-a74e-ede604f707b52025-10-23WarningsExact identifier
unii: 339NCG44TV
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycineGLYCINEICU Medical Inc.c10a4657-cf64-4a71-a247-363dd58993bc2025-10-21Warnings, Adverse reactionsExact identifier
unii: TE7660XO1C

Reported adverse events (FAERS/openFDA)#

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