Lantus

Product NDC: 64725-2220
11-digit product format: 647252220
Labeler code: 64725
Product ID: 64725-2220_7d9b3b09-2b30-40a4-8b37-38d2e6af3abf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin glargine
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: TYA Pharmaceuticals
Application: NDA021081
Marketing category: NDA
Marketing start: 2009-09-23
Marketing end: 0000-00-00
Substance: INSULIN GLARGINE
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin [Chemical/Ingredient],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	64725-2220		I	Inactivated by FDA		2026-08-17
excluded package	package	64725-2220	64725-2220-1	I	Inactivated by FDA		2026-08-17

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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`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	64725-2220-1	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021081-001	LANTUS	100 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2000-04-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021081-002	LANTUS SOLOSTAR	300 UNITS/3ML (100 UNITS/ML)	INJECTABLE / INJECTION	RLD, RS	2007-04-27	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8992486	2024-06-05		Drug product	2015-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9604009	2024-08-16		Drug product	2017-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9533105	2024-08-17		Drug product	2017-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9623189	2024-08-19		Drug product	2017-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9561331	2024-08-28		Drug product	2017-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8512297	2024-09-15		Drug product	2013-08-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	8679069	2025-04-12		Drug product	2014-03-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021081-002	9717852	2033-04-08		Drug product	2018-07-11	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930	2023-06-13		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652	2023-07-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7713930*PED	2023-12-13		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7476652*PED	2024-01-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833	2027-09-23		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-001	7918833*PED	2028-03-23		Pediatric extension		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8603044	2024-03-02		Drug product	2014-01-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9233211	2024-03-02		Drug product	2016-01-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9408979	2024-03-02		Drug product	2016-09-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9526844	2024-03-02		Drug product	2016-12-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9604008	2024-03-02		Drug product	2017-03-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9610409	2024-03-02		Drug product	2017-04-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9775954	2024-03-02		Drug product	2017-10-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9827379	2024-03-02	U-2146	Drug product	2017-11-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	8556864	2024-03-03		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021081-002	9011391	2024-03-26	U-1832		2015-05-01	`3f01610625f2…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a9e2da77-dd6b-4b0e-9065-a13f87955fe1	Product name	1	20220720
5f5c996a-6aad-4f9a-86a2-e09dc8b634cb	Product name	1	20220207
1c45812e-8815-4d17-83e9-a18ac8df9bad	Product name	1	20210105
256d5b66-c6d0-4302-bcdf-00cf53e72c3b	Product name	2	20200323
2e66a9ce-feca-49d1-97e2-3bec86a60bd8	Product name	2	20200323
e43198b7-315b-480b-8517-8809d5ca232a	Product name	2	20200323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-2220-1	2019-11-27	C162847	48780-1	9855e2a2-470d-60a7-e053-dbdaa90a05bd	These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-2220-1	Lantus	10 mL in 1 VIAL, GLASS	INJECTION, SOLUTION	10		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
insulin glargine	ACTIVE INGREDIENT	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
insulin glargine	ACTIVE MOIETY	2ZM8CX04RZ	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
METACRESOL	INACTIVE INGREDIENT	GGO4Y809LO	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-2220	LANTUS (INSULIN GLARGINE) INJECTION, SOLUTION [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20140927_6c81d894-67eb-4c68-8af1-8cc220adb6f5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2ZM8CX04RZ	INSULIN GLARGINE	160337-95-1	INSULIN GLARGINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311041	insulin glargine 100 UNT/ML Injectable Solution	PSN	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2
285018	Lantus 100 UNT/ML Injectable Solution	PSN	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2
285018	insulin glargine 100 UNT/ML Injectable Solution [Lantus]	SBD	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2
311041	insulin glargine 100 UNT/ML Injectable Solution	SCD	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2
311041	insulin analog, glargine 100 UNT/ML Injectable Solution	SY	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2
285018	Lantus 100 UNT/ML Injectable Solution	SY	6c81d894-67eb-4c68-8af1-8cc220adb6f5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64725-2220-1	64725222001	10 mL in 1 VIAL, GLASS	10 ml	Historical