Insulin Glargine-aldy
- Product NDC
- 87682-080
- 11-digit product format
- 876820080
- Labeler code
- 87682
- Product ID
- 87682-080_5df3635c-1735-2cb9-e063-6294a90aaacf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine-aldy
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Lanexa Biologics, LLC
- Application
- BLA761412
- Marketing category
- BLA
- Marketing start
- 2026-07-01
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Insulin Glargine-aldy
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INSULIN GLARGINE | 100 [iU]/mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761412 | Langlara | insulin glargine-aldy | 351(k) Interchangeable | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87682-080-05 | 87682008005 | 5 SYRINGE in 1 CARTON (87682-080-05) / 3 mL in 1 SYRINGE (87682-080-01) | 5 syringe | 2026-07-01 | No | No | Current |