Insulin lispro
- Product NDC
- 70518-2398
- Requested package NDC
- 70518-2398-0
- 11-digit product format
- 705182398
- Labeler code
- 70518
- Product ID
- 70518-2398_c8e8e7db-0881-6953-e053-2a95a90a3cc6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Insulin Lispro
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- REMEDYREPACK INC.
- Application
- BLA020563
- Marketing category
- BLA
- Marketing start
- 2019-10-30
- Marketing end
- 0000-00-00
- Substance
- INSULIN LISPRO
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin [Chemical/Ingredient],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 package | package | 70518-2398 | 70518-2398-0 | 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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|
| Humalog KwikPen | INSULIN LISPRO | Eli Lilly and Company | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f | 2026-06-16 | Warnings, Adverse reactions | BLA020563 |
| Insulin Lispro | INSULIN LISPRO | Eli Lilly and Company | 97d5e596-aae1-42c9-ae89-c3780959c467 | 2025-06-17 | Warnings, Adverse reactions | BLA020563 |
| HUMALOG | INSULIN LISPRO | A-S Medication Solutions | c6b8ff07-d3e2-457f-8a38-b60de60adf75 | 2025-04-01 | Warnings, Adverse reactions | BLA020563 |
| Insulin Lispro | INSULIN LISPRO | A-S Medication Solutions | 2be14cbb-197a-4da8-82c8-2443594e7f6f | 2024-05-31 | Warnings, Adverse reactions | BLA020563 |
| HUMALOG | INSULIN LISPRO | A-S Medication Solutions | 6ee01d2e-3525-4aa9-8ec1-5fb0f63dd47c | 2024-02-15 | Warnings, Adverse reactions | BLA020563 |
| Humalog KwikPen | INSULIN LISPRO | A-S Medication Solutions | 51d3dc11-52b9-4296-a2f4-58c770d4448d | 2024-01-24 | Warnings, Adverse reactions | BLA020563 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 020563 | Humalog | insulin lispro | 351(a) | Rx | 2026-08-01 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2398-0 | 70518239800 | 1 VIAL in 1 CARTON (70518-2398-0) > 10 mL in 1 VIAL | 1 vial | 2019-10-30 | 0000-00-00 | No | No | Current |