FDA.reportPublic FDA data

NOVOLOG

Product NDC
0169-2101
Requested package NDC
0169-2101-25
11-digit product format
001692101
Labeler code
0169
Product ID
0169-2101_de82c22d-ea25-44ef-8bcd-c3cda9e84e59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Novo Nordisk
Application
BLA020986
Marketing category
BLA
Marketing start
2003-01-22
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NOVOLOG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup
D933668QVXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311040Internal RxNorm lookup
351926Internal RxNorm lookup
1653196Internal RxNorm lookup
1653198Internal RxNorm lookup
1653202Internal RxNorm lookup
1653204Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a1e73a2-3009-40d0-876c-b4cb2be56fc5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-2101-12NOVOLOG3 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION334
0169-2101-25NOVOLOG5 in 1 CARTONINJECTION, SOLUTION534

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0169-2101-12ML - Milliliter0169-2101a4bf81bc-3d50-471d-95a6-af8b42caf14312025-05-14
0169-2101-25ML - Milliliter0169-21012a1610ae-4bc4-4086-9d19-c81413ea388012021-07-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
INSULIN ASPARTACTIVE INGREDIENTD933668QVXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
INSULIN ASPARTACTIVE MOIETYD933668QVXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
METACRESOLINACTIVE INGREDIENTGGO4Y809LONOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
PHENOLINACTIVE INGREDIENT339NCG44TVNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19
ZINCINACTIVE INGREDIENTJ41CSQ7QDSNOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-2101NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION) INJECTION, SOLUTION [NOVO NORDISK]34Current NDC, Legacy NDC, 2 package rows20250122_3a1e73a2-3009-40d0-876c-b4cb2be56fc5.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Insulin AspartINSULIN ASPARTREMEDYREPACK INC.b3d77cb0-cd47-441f-8f54-5329c655da9c2026-01-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTA-S Medication Solutionsc3e4c46e-5211-4f05-b7ab-1e9ad270876b2024-09-11Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTA-S Medication Solutionsbfd2b192-35e5-4773-ab73-802565b2ad782024-03-14Warnings, Adverse reactionsExact identifier
application number: BLA020986
NOVOLOGINSULIN ASPARTA-S Medication Solutions13891e5a-e57a-46e8-911c-2f680352b52b2023-12-15Warnings, Adverse reactionsExact identifier
application number: BLA020986
NOVOLOGINSULIN ASPARTA-S Medication Solutionse172b4f8-9b25-4019-8e09-afc10b2f30c92023-12-09Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin AspartINSULIN ASPARTNovo Nordisk Pharma, Inc.bee5b358-c863-420b-be73-ced2e920c4992023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
application number: BLA020986
ndc (package): 0169-2101-25
ndc (product): 0169-2101
ndc11 (package): 00169210125

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020986Novologinsulin aspart351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653196insulin aspart 100 UNT/ML in 3 ML CartridgePSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653202insulin aspart 100 UNT/ML in 3 ML Pen InjectorPSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
311040insulin aspart 100 UNT/ML Injectable SolutionPSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653198NovoLOG 100 UNT/ML in 3 ML CartridgePSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653204NovoLOG 100 UNT/ML in 3 ML Pen InjectorPSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
351926NovoLOG 100 UNT/ML Injectable SolutionPSN3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16531983 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog]SBD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16532043 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]SBD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
351926insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]SBD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16531963 ML insulin aspart, human 100 UNT/ML CartridgeSCD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16532023 ML insulin aspart, human 100 UNT/ML Pen InjectorSCD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
311040insulin aspart, human 100 UNT/ML Injectable SolutionSCD3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16531983 ML NovoLog 100 UNT/ML CartridgeSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
16532043 ML NovoLog 100 UNT/ML Pen InjectorSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
311040insulin analog, aspart 100 UNT/ML Injectable SolutionSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653196insulin, aspart, human 100 UNT/ML per 3 ML CartridgeSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653202insulin, aspart, human 100 UNT/ML per 3 ML Pen InjectorSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
351926NovoLog 100 UNT/ML Injectable SolutionSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653204NovoLog FlexPen 100 UNT/ML per 3 ML Pen InjectorSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534
1653204NovoLog FlexTouch 100 UNT/ML per 3 ML Pen InjectorSY3a1e73a2-3009-40d0-876c-b4cb2be56fc534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0169-2101-25001692101255 SYRINGE, PLASTIC in 1 CARTON (0169-2101-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-2101-12) 2021-05-250000-00-00NoNoCurrent