Novolin

Product NDC
0169-3007
11-digit product format
001693007
Labeler code
0169
Product ID
0169-3007_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
2018-06-01
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y17CTI5SRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213442Internal RxNorm lookup
311048Internal RxNorm lookup
847187Internal RxNorm lookup
2049380Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
508a2763-3cb7-4be5-9e53-544e84cd9b1fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1997359-a049-4781-b04b-084a7f3cb039Product name220200325
aa12d3c0-d2b4-4c50-9af0-cb08b230ec20Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-3007-01Novolin70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION318
0169-3007-12Novolin70/303 mL in 1 SYRINGE, PLASTICINJECTION, SUSPENSION318
0169-3007-15Novolin70/305 in 1 CARTONINJECTION, SUSPENSION518
0169-3007-25Novolin70/305 in 1 CARTONINJECTION, SUSPENSION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-3007-01ML - Milliliter0169-300793f5dcc1-eea8-40ad-ba23-8240ded7274e12018-11-06
0169-3007-12ML - Milliliter0169-30070a8699de-b2fd-4786-8fb6-529ad4f769dc12018-11-06
0169-3007-15ML - Milliliter0169-3007bbcae82c-f95a-4852-955a-90c5fbd57c5e12018-11-06
0169-3007-25ML - Milliliter0169-30078c855e92-eb6b-4eaf-9da7-9594b9343a9912018-11-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-3007NOVOLIN 70/30 (HUMAN INSULIN) INJECTION, SUSPENSION [NOVO NORDISK]18Current NDC, Legacy NDC, 4 package rows20221208_508a2763-3cb7-4be5-9e53-544e84cd9b1f.zip

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novolin 70/30HUMAN INSULINA-S Medication Solutionse825d7e9-467c-4f50-a6d6-f2602449c1de2023-02-06Warnings, Adverse reactionsExact identifier
application number: BLA019991
Novolin 70/30HUMAN INSULINNovo Nordisk508a2763-3cb7-4be5-9e53-544e84cd9b1f2022-11-23Warnings, Adverse reactionsExact identifier
application number: BLA019991
ndc (product): 0169-3007

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
019991Novolin 70/30insulin isophane human and insulin human351(a)OTC2026-07-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0169-3007-01001693007013 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-3007-12001693007123 mL in 1 SYRINGE, PLASTIC3 mlHistorical
0169-3007-15001693007155 SYRINGE, PLASTIC in 1 CARTON (0169-3007-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3007-01) 2018-06-010000-00-00NoNoCurrent
0169-3007-25001693007255 SYRINGE, PLASTIC in 1 CARTON (0169-3007-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3007-12) 2018-06-010000-00-00NoNoCurrent