NovoLog

Product NDC: 68258-8899
11-digit product format: 682588899
Labeler code: 68258
Product ID: 68258-8899_5d8213bc-800b-4e52-af9e-3ba3e5f2650c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin aspart
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Dispensing Solutions, Inc.
Application: NDA020986
Marketing category: NDA
Marketing start: 2003-01-22
Marketing end: 0000-00-00
Substance: INSULIN ASPART
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin [CS],Insulin Analog [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68258-8899		I	Inactivated by FDA		2026-08-11
excluded package	package	68258-8899	68258-8899-3	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-8899-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-8899-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-8899-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-8899-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-8899-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-8899-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-8899-3	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-8899-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-8899-3	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-8899-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-8899-3	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-8899-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-8899-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-8899-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-8899-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-8899-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-8899-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-8899-3	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-8899-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-8899-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-8899-3	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-8899-3	`110d247fa046…`	`a55b01930146…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-8899-3	2019-11-27	C162847	48780-1	9855d018-d5ce-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use NovoLog safely and effectively. See full prescribing information for NovoLog. NovoLog ® (insulin aspart [rDNA origin] injection) solution for subcutaneous use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8899-3	NovoLog	3 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-8899-3	ML - Milliliter	68258-8899	a02592f3-2fa7-4efb-b0b1-c7e6893acf5c	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
68258-8899	NOVOLOG (INSULIN ASPART) INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 1 package rows	20130724_cd88e313-6193-4413-beff-7d955580060d.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
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	Status
68258-8899-3	68258889903	3 mL in 1 SYRINGE, PLASTIC	3 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NovoLog	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2013-07-23	HUMAN PRESCRIPTION DRUG LABEL	1