SEMGLEE

Product NDC: 49502-251
11-digit product format: 495020251
Labeler code: 49502
Product ID: 49502-251_b9b88b11-1b0d-45c3-b9d0-fbcc2f0e2953
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: insulin glargine-yfgn
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Mylan Specialty L.P.
Application: BLA761201
Marketing category: BLA
Marketing start: 2021-11-15
Marketing end: 0000-00-00
Substance: INSULIN GLARGINE
Active strength: 100 [iU]/mL
Pharmacologic classes: Insulin Analog [EPC], Insulin [CS]
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49502-251		D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-35	D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-71	D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-73	D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-75	D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-98	D	Discontinued by firm	2026-08-17
excluded package	package	49502-251	49502-251-99	D	Discontinued by firm	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 · 42 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	49502-251-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-251-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-251-98	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-251-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-251-75	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49502-251-73	`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	49502-251-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-251-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-251-98	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-251-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-251-75	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-251-73	`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	49502-251-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-251-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-251-98	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-251-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-251-75	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49502-251-73	`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	49502-251-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-251-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-251-98	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-251-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-251-75	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49502-251-73	`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	49502-251-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-251-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-251-98	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-251-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-251-75	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49502-251-73	`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	49502-251-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-251-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-251-98	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-251-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-251-75	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49502-251-73	`cdf11ea48f46…`	`ba0047e9e063…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-251-71	ML - Milliliter	49502-251	92d58f6e-471c-4609-af59-39c4942b531a	1	2021-11-09
49502-251-75	ML - Milliliter	49502-251	9a7db8ed-8741-4e58-acec-bc93956d5878	1	2021-10-08

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Insulin Glargine	INSULIN GLARGINE-YFGN	Biocon Biologics Inc.	3ac85ebb-5594-59c8-77fd-df254329d151	2026-01-23	Warnings, Adverse reactions	Exact identifier application number: BLA761201
INSULIN GLARGINE	INSULIN GLARGINE-YFGN	Civica, Inc.	72cfe377-52f6-0348-fc71-5d4ac1992ffb	2025-07-24	Warnings, Adverse reactions	Exact identifier application number: BLA761201
INSULIN GLARGINE	INSULIN GLARGINE-YFGN	Civica, Inc.	216f2167-c201-76fe-81ed-0d51fe53832f	2025-07-03	Warnings, Adverse reactions	Exact identifier application number: BLA761201
SEMGLEE	INSULIN GLARGINE-YFGN	Biocon Biologics Inc.	8cf5544f-87d6-468b-f6ae-898b1fdb5d80	2025-03-03	Warnings, Adverse reactions	Exact identifier application number: BLA761201

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761201	Semglee	insulin glargine-yfgn	351(k) Interchangeable	Rx	2026-07-01

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-251-35	49502025135	1 SYRINGE in 1 CARTON (49502-251-35) > 3 mL in 1 SYRINGE	1 syringe	2022-10-01	0000-00-00	Yes	No	Current
49502-251-71	49502025171	1 SYRINGE in 1 CARTON (49502-251-71) > 3 mL in 1 SYRINGE	1 syringe	2022-10-01	0000-00-00	No	No	Current
49502-251-73	49502025173	3 SYRINGE in 1 CARTON (49502-251-73) > 3 mL in 1 SYRINGE	3 syringe	2022-10-01	0000-00-00	No	No	Current
49502-251-75	49502025175	5 SYRINGE in 1 CARTON (49502-251-75) > 3 mL in 1 SYRINGE	5 syringe	2021-11-15	0000-00-00	No	No	Current
49502-251-98	49502025198	3 SYRINGE in 1 CARTON (49502-251-98) > 3 mL in 1 SYRINGE	3 syringe	2022-10-01	0000-00-00	Yes	No	Current
49502-251-99	49502025199	5 SYRINGE in 1 CARTON (49502-251-99) > 3 mL in 1 SYRINGE	5 syringe	2022-10-01	0000-00-00	Yes	No	Current