FDA.reportPublic FDA data

Novolin

Product NDC
0169-1837
11-digit product format
001691837
Labeler code
0169
Product ID
0169-1837_c7164ea1-aa3e-4359-a3f0-a34c78e78398
Type
HUMAN OTC DRUG
Nonproprietary name
Human Insulin
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA019991
Marketing category
BLA
Marketing start
1991-06-25
Substance
INSULIN HUMAN
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin [CS], Insulin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Novolin
Brand name suffix
70/30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN HUMAN100 [iU]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y17CTI5SR
Rxcui213442, 311048, 847187, 2049380

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-1837-02Novolin70/3010 mL in 1 VIALINJECTION, SUSPENSION1018
0169-1837-02Novolin70/301 in 1 CARTONINJECTION, SUSPENSION118
0169-1837-11Novolin70/301 in 1 CARTONINJECTION, SUSPENSION118
0169-1837-11Novolin70/3010 mL in 1 VIALINJECTION, SUSPENSION1018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-1837-02ML - Milliliter0169-183760a3b25e-a889-482d-b1b7-b570840838b512013-02-13
0169-1837-11ML - Milliliter0169-18372a96ef93-f20b-41f1-8528-3a8e1e8ff9b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]9
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
INSULIN HUMANACTIVE INGREDIENT1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
INSULIN HUMANACTIVE MOIETY1Y17CTI5SRNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
PROTAMINE SULFATEINACTIVE INGREDIENT0DE9724IHCNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [PHYSICIANS TOTAL CARE, INC.]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BNOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-1837NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]18Current NDC, Legacy NDC, 4 package rows20221208_508a2763-3cb7-4be5-9e53-544e84cd9b1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847187insulin isophane, human 70 UNT/ML / insulin, human UNT/ML in 3 ML Pen InjectorPSN508a2763-3cb7-4be5-9e53-544e84cd9b1f18
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSN508a2763-3cb7-4be5-9e53-544e84cd9b1f18
2049380NovoLIN 70/30 in 3 ML Pen InjectorPSN508a2763-3cb7-4be5-9e53-544e84cd9b1f18
213442NovoLIN 70/30 Injectable SuspensionPSN508a2763-3cb7-4be5-9e53-544e84cd9b1f18
20493803 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen Injector [Novolin]SBD508a2763-3cb7-4be5-9e53-544e84cd9b1f18
213442insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]SBD508a2763-3cb7-4be5-9e53-544e84cd9b1f18
8471873 ML insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Pen InjectorSCD508a2763-3cb7-4be5-9e53-544e84cd9b1f18
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCD508a2763-3cb7-4be5-9e53-544e84cd9b1f18
847187insulin isophane, human 70 UNT/ML / insulin, human UNT/ML per 3 ML Pen InjectorSY508a2763-3cb7-4be5-9e53-544e84cd9b1f18
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSY508a2763-3cb7-4be5-9e53-544e84cd9b1f18
213442Novolin 70/30 Injectable SuspensionSY508a2763-3cb7-4be5-9e53-544e84cd9b1f18
2049380Novolin 70/30 per 3 ML Pen InjectorSY508a2763-3cb7-4be5-9e53-544e84cd9b1f18
213442Relion Novolin 70/30 Injectable SuspensionSY508a2763-3cb7-4be5-9e53-544e84cd9b1f18
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSNe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442NovoLIN 70/30 Injectable SuspensionPSNe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]SBDe825d7e9-467c-4f50-a6d6-f2602449c1de14
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCDe825d7e9-467c-4f50-a6d6-f2602449c1de14
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442Novolin 70/30 Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14
213442Relion Novolin 70/30 Injectable SuspensionSYe825d7e9-467c-4f50-a6d6-f2602449c1de14
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSN8c7038f4-60d4-4604-814d-74921cdc1ad82
311048insulin, human isophane / insulin regular 70/30 Injectable SuspensionPSN0cc57309-01ef-4a02-8d27-b981c768135a2
213442NovoLIN 70/30 Injectable SuspensionPSN8c7038f4-60d4-4604-814d-74921cdc1ad82
213442NovoLIN 70/30 Injectable SuspensionPSN0cc57309-01ef-4a02-8d27-b981c768135a2
213442insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]SBD8c7038f4-60d4-4604-814d-74921cdc1ad82
213442insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable Suspension [Novolin]SBD0cc57309-01ef-4a02-8d27-b981c768135a2
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCD8c7038f4-60d4-4604-814d-74921cdc1ad82
311048insulin isophane, human 70 UNT/ML / insulin, regular, human 30 UNT/ML Injectable SuspensionSCD0cc57309-01ef-4a02-8d27-b981c768135a2
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSY8c7038f4-60d4-4604-814d-74921cdc1ad82
311048insulin, human mixed 70/30 100 UNT/ML Injectable SuspensionSY0cc57309-01ef-4a02-8d27-b981c768135a2
213442Novolin 70/30 Injectable SuspensionSY8c7038f4-60d4-4604-814d-74921cdc1ad82
213442Novolin 70/30 Injectable SuspensionSY0cc57309-01ef-4a02-8d27-b981c768135a2
213442Relion Novolin 70/30 Injectable SuspensionSY0cc57309-01ef-4a02-8d27-b981c768135a2
213442Relion Novolin 70/30 Injectable SuspensionSY8c7038f4-60d4-4604-814d-74921cdc1ad82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-1837-02001691837021 VIAL in 1 CARTON (0169-1837-02) / 10 mL in 1 VIAL1 vial1991-06-250000-00-00NoNoCurrent
0169-1837-11001691837111 VIAL in 1 CARTON (0169-1837-11) / 10 mL in 1 VIAL1 vial1991-06-250000-00-00NoNoCurrent