NOVOLOG

Product NDC: 0169-6339
11-digit product format: 001696339
Labeler code: 0169
Product ID: 0169-6339_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
Ingredient	Strength
INSULIN ASPART	100 [iU]/mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	D933668QVX, 059QF0KO0R
Rxcui	311040, 351926, 1653196, 1653198, 1653202, 1653204

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
24eab60a-55c8-40c1-8c86-7ed01a7a8bef	Product name	1	20240227
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
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
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0169-6339-10	NOVOLOG	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	34
0169-6339-10	NOVOLOG	5 in 1 CARTON	INJECTION, SOLUTION	5	34
0169-6339-90	NOVOLOG	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3	34
0169-6339-97	NOVOLOG	1 in 1 CARTON	INJECTION, SOLUTION	1	34
0169-6339-98	NOVOLOG	1 in 1 CARTON	INJECTION, SOLUTION	1	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-6339-10	ML - Milliliter	0169-6339	ad3dda81-4f5a-4c6b-8ce2-39f5d9aa2c43	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 [DISPENSING SOLUTIONS, INC.]	1
INSULIN ASPART	ACTIVE MOIETY	D933668QVX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-6339	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION) INJECTION, SOLUTION [NOVO NORDISK]	34	Current NDC, Legacy NDC, 5 package rows	20250122_3a1e73a2-3009-40d0-876c-b4cb2be56fc5.zip

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
1653202	insulin aspart 100 UNT/ML in 3 ML Pen Injector	PSN	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653204	NovoLOG 100 UNT/ML in 3 ML Pen Injector	PSN	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653204	3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]	SBD	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653202	3 ML insulin aspart, human 100 UNT/ML Pen Injector	SCD	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653204	3 ML NovoLog 100 UNT/ML Pen Injector	SY	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653202	insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector	SY	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653204	NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector	SY	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653204	NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector	SY	13891e5a-e57a-46e8-911c-2f680352b52b	6
1653202	insulin aspart 100 UNT/ML in 3 ML Pen Injector	PSN	cd88e313-6193-4413-beff-7d955580060d	1
1653204	NovoLOG 100 UNT/ML in 3 ML Pen Injector	PSN	cd88e313-6193-4413-beff-7d955580060d	1
1653204	3 ML insulin aspart, human 100 UNT/ML Pen Injector [NovoLog]	SBD	cd88e313-6193-4413-beff-7d955580060d	1
1653202	3 ML insulin aspart, human 100 UNT/ML Pen Injector	SCD	cd88e313-6193-4413-beff-7d955580060d	1
1653204	3 ML NovoLog 100 UNT/ML Pen Injector	SY	cd88e313-6193-4413-beff-7d955580060d	1
1653202	insulin, aspart, human 100 UNT/ML per 3 ML Pen Injector	SY	cd88e313-6193-4413-beff-7d955580060d	1
1653204	NovoLog FlexPen 100 UNT/ML per 3 ML Pen Injector	SY	cd88e313-6193-4413-beff-7d955580060d	1
1653204	NovoLog FlexTouch 100 UNT/ML per 3 ML Pen Injector	SY	cd88e313-6193-4413-beff-7d955580060d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-6339-10	00169633910	5 SYRINGE, PLASTIC in 1 CARTON (0169-6339-10) / 3 mL in 1 SYRINGE, PLASTIC		2003-01-22	0000-00-00	No	No	Current
0169-6339-90	00169633990	3 mL in 1 SYRINGE, PLASTIC	3 ml					Historical
0169-6339-97	00169633997	1 in 1 CARTON						Historical
0169-6339-98	00169633998	1 SYRINGE, PLASTIC in 1 CARTON (0169-6339-98) / 3 mL in 1 SYRINGE, PLASTIC (0169-6339-90)		2003-01-22	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NOVOLOG	A-S Medication Solutions	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	6
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	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-23	HUMAN PRESCRIPTION DRUG LABEL	1

NOVOLOG

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#