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 13 of 37 · 727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
BUDDATE INONOTUS OBLIQUUS WATER BRILLIANCE MASKBUTYLENE GLYCOL, GLYCERIN, INONOTUS OBLIQUUS (MUSHROOM) EXTRACTBUDDATE Co Ltd464988ad-557e-13f5-e054-00144ff8d46c2025-11-30WarningsExact identifier
unii: PDC6A3C0OX
BUDDATE LOTUS MOISTURE ESSENCEGLYCERIN, NIACINAMIDE, NELUMBO NUCIFERA FLOWER EXTRACT, PORTULACA OLERACEA EXTRACTBUDDATE Co Ltd46499995-8b13-3e5c-e054-00144ff88e882025-11-30WarningsExact identifier
unii: PDC6A3C0OX
JBA ATIV ELECTROLYTE ORS LAVENDER LEMONADEPOTASSIUM,MAGNESIUM,ZINCAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals6356c6c3-4c7e-4d4b-aecb-60b92ebf5f1e2025-11-28WarningsExact identifier
unii: J41CSQ7QDS
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
COLD/FLU HPARSENICTRIOXIDE,BAPTISIATINCTORIAROOT,BRYONIAALBAROOT,SOLANUMDULCAMARATOP,ECHINACEAANGUSTIFOLIA,ECHINACEAPURPUREA,EUPATORIUMPERFOLIATUMFLOWERINGTOP,FERROSOFERRICPHOSPHATE,GELSEMIUMSEMPERVIRENSROOT,POTASSIUMCHLORIDE,PHOSPHORUS,ANEMONEPULSATILLA,SULFUR,ZINCACETATEANHYDROUS,ZINCCARBONATE,ZINC,ZINCCHLORIDE,ZINCOXIDE,ZINCPICRATENONAHYRDATE,ZINCVALERATEDIHYDRATE,CAIRINAMOSCHATAHEART/LIVERAUTOLYSATE,INFLUENZINUMNatural Creations, Inc.11d945ea-3b03-42cc-b1c0-e4c517e386f62025-11-20WarningsExact identifier
unii: J41CSQ7QDS
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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