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 15 of 37 · 727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycerinGLYCERINChain Drug Consortium LLC022dd494-cb3c-4fa7-be99-4c38fabdc6122025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.5e97c4d2-e41d-5bb6-e053-2a91aa0a31632025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCVS Pharmacy94e4a6f3-43d0-b2a5-e053-2a95a90aa1152025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.5e83d3ef-91c5-1c3a-e053-2a91aa0a93ed2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f3bc-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINRite Aid Corporation5da2ea79-f37a-b82b-e053-2a91aa0af0af2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINDSC Laboratories Inc.a381838b-d1ae-11c5-e053-2a95a90a7bcb2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacy90a4d385-d548-420b-91d2-54d5e819fcce2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCVS Pharmacy3a59c4a9-5f86-406a-e054-00144ff8d46c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Health7e7e9366-af1e-e0ff-e053-2a91aa0a94872025-10-24WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINCardinal Healthc2b02afc-5a8a-2a25-e053-2a95a90ae45c2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Hemorrhoidal Cream (with applicator)PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN, PETROLATUMBETTER LIVING BRANDS, LLCb026a386-5e38-52ed-e053-2a95a90a6b0e2025-10-24WarningsExact identifier
unii: PDC6A3C0OX
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
unii: PDC6A3C0OX
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: J41CSQ7QDS
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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