FDA.reportPublic FDA data

NDC 0169-3003-01 - Novolin R

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
0169-3003
Requested NDC
0169-3003-01
Package NDCs from labels
0169-3003-01, 0169-3003-15, 0169-3003-12, 0169-3003-25
Manufacturer
Novo Nordisk
Effective date
2022-11-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Novolin R - Novo NordiskNovo Nordisk2022-11-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3003-01NovolinR3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION319
0169-3003-12NovolinR3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION319
0169-3003-15NovolinR5 in 1 CARTONINJECTION, SOLUTION519
0169-3003-25NovolinR5 in 1 CARTONINJECTION, SOLUTION519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3003NOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]19Current NDC, Legacy NDC, 4 package rows20221208_aee7f1f3-612c-4027-8ce9-4fd1f41eed71.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3003-01ML - Milliliter0169-3003476b3f63-aa36-4fed-9ed4-21549f6e3b1012021-04-08
0169-3003-12ML - Milliliter0169-30034b0b8f92-b40a-4627-9199-59fd02f0cf9812022-06-06
0169-3003-15ML - Milliliter0169-300395639287-ef66-4d48-9d5f-cb16b204833a12020-01-03
0169-3003-25ML - Milliliter0169-3003653bc94f-b955-47ac-830e-17376b76664012020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN R (HUMAN INSULIN) INJECTION, SOLUTION [NOVO NORDISK]12

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 37 · 727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Male Balance Liquescence 3034MALE BALANCE LIQUESCENCEProfessional Complementary Health Formulas8e0eb969-d946-469e-b2af-375eb5ad931e2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Oxy Bee Pollen Liquescence 3012OXY BEE POLLEN LIQUESCENCEProfessional Complementary Health Formulas2d6cade7-7e1b-4859-b538-9d0ab70cccb82026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Pancreas DB Liquescence 3037PANCREAS DB LIQUESCENCEProfessional Complementary Health Formulas30bc86e9-538b-449a-af48-99aafc4059242026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Pain Formula II Drops 2090PAIN FORMULA II DROPSProfessional Complementary Health Formulasb395d69b-8e6b-4ffc-9d6e-2ecd503aa1772026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Hysteria Drops 2119HYSTERIA DROPSProfessional Complementary Health Formulas7fe11cce-22f4-47e8-8006-ff5b2b2b23712026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Male Endocrine Axis Drops 5019MALE ENDOCRINE AXIS DROPSProfessional Complementary Health Formulas607dd42d-5b41-4c0a-8499-83763dc04ad12026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Epilepsy Drops 2020EPILEPSY DROPSProfessional Complementary Health Formulasb5cc19d2-5200-498c-9742-5967d90479282026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Mycotoxin Inhibitor 6020MYCOTOXIN INHIBITORProfessional Complementary Health Formulasb9e7062b-f5e0-462a-8192-215c5a6472202026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Insomnia Drops 2035INSOMNIA DROPSProfessional Complementary Health Formulas49dcc73f-2a20-4938-8671-0fa9dd39d5b82026-01-08WarningsExact identifier
unii: J41CSQ7QDS
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Neuro Relax Drops 2055NEURO RELAX DROPSProfessional Complementary Health Formulas50cf1c24-4ae9-42e8-a2a3-4d83cc5bfb5a2026-01-08WarningsExact identifier
unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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