Insulin Glargine
- Product NDC
- 49502-394
- 11-digit product format
- 495020394
- Labeler code
- 49502
- Product ID
- 49502-394_a14de887-e390-4d3f-8863-48ca77969e2e
- 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
- 2021-11-16
- Marketing end
- 0000-00-00
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin [CS],Insulin Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49502-394 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 49502-394 | 49502-394-75 | D | Discontinued by firm | 2026-09-14 |
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.
| 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 | 49502-394-75 | 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 | 49502-394-75 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49502-394-71 | ML - Milliliter | 49502-394 | 13f54672-5b68-45ba-82bc-9ef1608971fa | 1 | 2021-11-09 |
| 49502-394-75 | ML - Milliliter | 49502-394 | c6c7cd70-be13-4c39-a934-30423d481e7b | 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.
| 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 | BLA761201 |
| INSULIN GLARGINE | INSULIN GLARGINE-YFGN | Civica, Inc. | 72cfe377-52f6-0348-fc71-5d4ac1992ffb | 2025-07-24 | Warnings, Adverse reactions | BLA761201 |
| INSULIN GLARGINE | INSULIN GLARGINE-YFGN | Civica, Inc. | 216f2167-c201-76fe-81ed-0d51fe53832f | 2025-07-03 | Warnings, Adverse reactions | BLA761201 |
| SEMGLEE | INSULIN GLARGINE-YFGN | Biocon Biologics Inc. | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 2025-03-03 | Warnings, Adverse reactions | BLA761201 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761201 | Semglee | insulin glargine-yfgn | 351(k) Interchangeable | Rx | 2026-08-01 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49502-394-75 | 49502039475 | 5 SYRINGE in 1 CARTON (49502-394-75) > 3 mL in 1 SYRINGE (49502-394-71) | 5 syringe | 2021-11-16 | 0000-00-00 | No | No | Current |