NOVOLOG

Product NDC: 0169-7501
Requested package NDC: 0169-7501-11
11-digit product format: 001697501
Labeler code: 0169
Product ID: 0169-7501_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: 2001-08-27
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
Ingredient	Strength
INSULIN ASPART	100 [iU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
059QF0KO0R	Internal UNII lookup
D933668QVX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3a1e73a2-3009-40d0-876c-b4cb2be56fc5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
24eab60a-55c8-40c1-8c86-7ed01a7a8bef	Product name	1	20240227
09fb02dd-baf0-4f67-b464-599bf26324b6	Product name	2	20200323
6a6ef80c-37d6-4e02-aa78-fce7b811234e	Product name	2	20200323
91ae268d-ee0f-6988-629d-5065a4376a50	Product name	2	20200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0169-7501-11	NOVOLOG	1 in 1 CARTON	INJECTION, SOLUTION	1	34
0169-7501-11	NOVOLOG	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	34
0169-7501-90	NOVOLOG	1 in 1 CARTON	INJECTION, SOLUTION	1	34
0169-7501-90	NOVOLOG	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-7501-11	ML - Milliliter	0169-7501	3335d742-93db-4818-a6ea-e76613acd4b4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
INSULIN ASPART	ACTIVE INGREDIENT	D933668QVX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
INSULIN ASPART	ACTIVE MOIETY	D933668QVX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [NOVO NORDISK]	19
INSULIN ASPART	ACTIVE INGREDIENT	D933668QVX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
INSULIN ASPART	ACTIVE MOIETY	D933668QVX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-7501	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	34	Current NDC, Legacy NDC, 4 package rows	20250122_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Aspart	INSULIN ASPART	REMEDYREPACK INC.	b3d77cb0-cd47-441f-8f54-5329c655da9c	2026-01-14	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Aspart	INSULIN ASPART	A-S Medication Solutions	c3e4c46e-5211-4f05-b7ab-1e9ad270876b	2024-09-11	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Aspart	INSULIN ASPART	A-S Medication Solutions	bfd2b192-35e5-4773-ab73-802565b2ad78	2024-03-14	Warnings, Adverse reactions	Exact identifier application number: BLA020986
NOVOLOG	INSULIN ASPART	A-S Medication Solutions	13891e5a-e57a-46e8-911c-2f680352b52b	2023-12-15	Warnings, Adverse reactions	Exact identifier application number: BLA020986
NOVOLOG	INSULIN ASPART	A-S Medication Solutions	e172b4f8-9b25-4019-8e09-afc10b2f30c9	2023-12-09	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Aspart	INSULIN ASPART	Novo Nordisk Pharma, Inc.	bee5b358-c863-420b-be73-ced2e920c499	2023-02-28	Warnings, Adverse reactions	Exact identifier application number: BLA020986
Insulin Diluting Medium for NovoLog	WATER INJECTION	Novo Nordisk	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	2023-02-28	Warnings, Adverse reactions	Exact identifier application number: BLA020986 ndc (package): 0169-7501-11 ndc (product): 0169-7501 ndc11 (package): 00169750111

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
020986	Novolog	insulin aspart	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D933668QVX	INSULIN ASPART	116094-23-6	INSULIN ASPART

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1653196	insulin aspart 100 UNT/ML in 3 ML Cartridge	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653202	insulin aspart 100 UNT/ML in 3 ML Pen Injector	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
311040	insulin aspart 100 UNT/ML Injectable Solution	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653198	NovoLOG 100 UNT/ML in 3 ML Cartridge	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653204	NovoLOG 100 UNT/ML in 3 ML Pen Injector	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
351926	NovoLOG 100 UNT/ML Injectable Solution	PSN	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653198	3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog]	SBD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653204	3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]	SBD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
351926	insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]	SBD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653196	3 ML insulin aspart, human 100 UNT/ML Cartridge	SCD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653202	3 ML insulin aspart, human 100 UNT/ML Pen Injector	SCD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
311040	insulin aspart, human 100 UNT/ML Injectable Solution	SCD	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653198	3 ML NovoLog 100 UNT/ML Cartridge	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653204	3 ML NovoLog 100 UNT/ML Pen Injector	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
311040	insulin analog, aspart 100 UNT/ML Injectable Solution	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653196	insulin, aspart, human 100 UNT/ML per 3 ML Cartridge	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653202	insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
351926	NovoLog 100 UNT/ML Injectable Solution	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653204	NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653204	NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector	SY	3a1e73a2-3009-40d0-876c-b4cb2be56fc5	34
1653196	insulin aspart 100 UNT/ML in 3 ML Cartridge	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	insulin aspart 100 UNT/ML in 3 ML Pen Injector	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin aspart 100 UNT/ML Injectable Solution	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	NovoLOG 100 UNT/ML in 3 ML Cartridge	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLOG 100 UNT/ML in 3 ML Pen Injector	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	NovoLOG 100 UNT/ML Injectable Solution	PSN	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	3 ML insulin aspart, human 100 UNT/ML Cartridge [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]	SBD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653196	3 ML insulin aspart, human 100 UNT/ML Cartridge	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	3 ML insulin aspart, human 100 UNT/ML Pen Injector	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin aspart, human 100 UNT/ML Injectable Solution	SCD	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653198	3 ML NovoLog 100 UNT/ML Cartridge	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	3 ML NovoLog 100 UNT/ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin analog, aspart 100 UNT/ML Injectable Solution	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653196	insulin, aspart, human 100 UNT/ML per 3 ML Cartridge	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653202	insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
351926	NovoLog 100 UNT/ML Injectable Solution	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
1653204	NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector	SY	e172b4f8-9b25-4019-8e09-afc10b2f30c9	28
311040	insulin aspart 100 UNT/ML Injectable Solution	PSN	66472b3d-32c1-4803-aff4-b621aa5430b3	2
351926	NovoLOG 100 UNT/ML Injectable Solution	PSN	66472b3d-32c1-4803-aff4-b621aa5430b3	2
351926	insulin aspart, human 100 UNT/ML Injectable Solution [NovoLog]	SBD	66472b3d-32c1-4803-aff4-b621aa5430b3	2
311040	insulin aspart, human 100 UNT/ML Injectable Solution	SCD	66472b3d-32c1-4803-aff4-b621aa5430b3	2
311040	insulin analog, aspart 100 UNT/ML Injectable Solution	SY	66472b3d-32c1-4803-aff4-b621aa5430b3	2
351926	NovoLog 100 UNT/ML Injectable Solution	SY	66472b3d-32c1-4803-aff4-b621aa5430b3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-7501-11	00169750111	1 VIAL, GLASS in 1 CARTON (0169-7501-11) / 10 mL in 1 VIAL, GLASS	2001-08-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOVOLOG	A-S Medication Solutions	2023-12-09	HUMAN PRESCRIPTION DRUG LABEL	28
NOVOLOG	Novo Nordisk	2023-02-28	HUMAN PRESCRIPTION DRUG LABEL	34
NOVOLOG	REMEDYREPACK INC.	2022-03-25	HUMAN PRESCRIPTION DRUG LABEL	4
NovoLog	TYA Pharmaceuticals	2014-04-25	HUMAN PRESCRIPTION DRUG LABEL	2