Lantus
- Product NDC
- 0088-5021
- 11-digit product format
- 000885021
- Labeler code
- 0088
- Product ID
- 0088-5021_7bfa39ee-1e03-4743-bf22-27cf983343c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- sanofi-aventis U.S. LLC
- Application
- BLA021081
- Marketing category
- BLA
- Marketing start
- 2017-06-04
- 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
- 2023-12-31
- 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 | 0088-5021 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 0088-5021 | 0088-5021-01 | 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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
DailyMed Product Concepts#
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0088-5021-01 | ML - Milliliter | 0088-5021 | b0d181fb-2e3a-44de-b768-d9ccaf210044 | 1 | 2017-07-07 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Lantus Solostar | INSULIN GLARGINE | sanofi-aventis U.S. LLC | d5e07a0c-7e14-4756-9152-9fea485d654a | 2025-06-02 | Warnings, Adverse reactions | BLA021081 |
| Insulin Glargine Solostar | INSULIN GLARGINE | A-S Medication Solutions | 9835904f-64f5-42b3-9ac9-89e4aaa5182a | 2023-11-01 | Warnings, Adverse reactions | BLA021081 |
| LANTUS SOLOSTAR | INSULIN GLARGINE | A-S Medication Solutions | 3a97c40f-0c83-42d7-a8ee-484b208db4e3 | 2023-07-22 | Warnings, Adverse reactions | BLA021081 |
| Lantus Solostar | INSULIN GLARGINE | A-S Medication Solutions | 632d9f68-f184-43d5-b184-a3af23f12ad9 | 2023-06-06 | Warnings, Adverse reactions | BLA021081 |
| Lantus | INSULIN GLARGINE | A-S Medication Solutions | ae27bb66-5dbe-4f01-a89e-f4fa7cb09c99 | 2023-02-04 | Warnings, Adverse reactions | BLA021081 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 021081 | Lantus | insulin glargine | 351(a) | Rx | 2026-07-01 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0088-5021-01 | 00088502101 | 1 VIAL, GLASS in 1 PACKAGE (0088-5021-01) > 10 mL in 1 VIAL, GLASS | 2017-06-04 | 0000-00-00 | No | No | Current |