Levemir
- Product NDC
- 50090-4501
- Requested package NDC
- 50090-4501-0
- 11-digit product format
- 500904501
- Labeler code
- 50090
- Product ID
- 50090-4501_826ae8d7-38e5-4686-84ae-4a698a8d86b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin detemir
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- A-S Medication Solutions
- Application
- BLA021536
- Marketing category
- BLA
- Marketing start
- 2013-10-31
- Marketing end
- 0000-00-00
- Substance
- INSULIN DETEMIR
- 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 | 50090-4501 | 50090-4501-0 | 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… |
FDA-Initiated Inactive NDC Indexing#
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 |
|---|---|---|---|---|---|---|
| Levemir | INSULIN DETEMIR | A-S Medication Solutions | 82192527-99aa-4b53-8ce9-9173668d309c | 2024-10-09 | Warnings, Adverse reactions | BLA021536 |
| Levemir | INSULIN DETEMIR | Novo Nordisk | d38d65c1-25bf-401d-9c7e-a2c3222da8af | 2022-12-08 | Warnings, Adverse reactions | BLA021536 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 021536 | Levemir | insulin detemir | 351(a) | Disc | 2026-07-01 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-4501-0 | 50090450100 | 5 SYRINGE, PLASTIC in 1 CARTON (50090-4501-0) > 3 mL in 1 SYRINGE, PLASTIC | 2019-09-04 | 0000-00-00 | No | No | Current |