BASAGLAR
- Product NDC
- 0002-8214
- 11-digit product format
- 000028214
- Labeler code
- 0002
- Product ID
- 0002-8214_3c2283e6-2844-44d2-a447-579b07e77c27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Insulin glargine
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Eli Lilly and Company
- Application
- BLA205692
- Marketing category
- BLA
- Marketing start
- 2015-12-16
- Marketing end
- 2026-07-27
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BASAGLAR
- Brand name suffix
- Tempo Pen
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INSULIN GLARGINE | 100 [iU]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2ZM8CX04RZ |
| Rxcui | 847230, 1736863, 2268064, 2268065 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0002-8214-01 | BASAGLAR Tempo Pen | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | 34 | |
| 0002-8214-05 | BASAGLAR Tempo Pen | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 34 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0002-8214-01 | ML - Milliliter | 0002-8214 | 7fd3f859-a424-483f-afeb-40a889949b53 | 1 | 2022-12-07 |
| 0002-8214-05 | ML - Milliliter | 0002-8214 | 96a02779-1c08-4c9d-9d09-68482da5bb08 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0002-8214 | BASAGLAR KWIKPEN (INSULIN GLARGINE) INJECTION, SOLUTION BASAGLAR TEMPO PEN (INSULIN GLARGINE) INJECTION, SOLUTION [ELI LILLY AND COMPANY] | 33 | Current NDC, Legacy NDC, 2 package rows | 20231214_0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1736863 | Basaglar KwikPen 100 UNT/ML in 3 ML Pen Injector | PSN | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268065 | Basaglar Tempo 100 UNT/ML in 3 ML Pen Injector | PSN | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 847230 | insulin glargine 100 UNT/ML in 3 ML Pen Injector | PSN | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268064 | insulin glargine 100 UNT/ML in 3 ML Pen Injector with Sensor | PSN | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 1736863 | 3 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar] | SBD | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268065 | Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector [Basaglar] | SBD | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 847230 | 3 ML insulin glargine 100 UNT/ML Pen Injector | SCD | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268064 | Sensor 3 ML insulin glargine 100 UNT/ML Pen Injector | SCD | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 1736863 | 3 ML Basaglar 100 UNT/ML Pen Injector | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 847230 | 3 ML insulin analog, glargine 100 UNT/ML Pen Injector | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268065 | Basaglar 100 UNT/ML per 3 ML Pen Injector with Sensor | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 1736863 | Basaglar 300 UNT per 3 ML Pen Injector | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268065 | Basaglar 300 UNT per 3 ML Pen Injector with Sensor | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 847230 | insulin analog, glargine 300 UNT Pen Injector | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268064 | insulin glargine 100 UNT/ML per 3 ML Pen Injector with Sensor | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 847230 | insulin glargine 300 UNT per 3 ML Pen Injector | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
| 2268064 | insulin glargine 300 UNT per 3 ML Pen Injector with Sensor | SY | 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae | 34 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0002-8214-01 | 00002821401 | 3 mL in 1 SYRINGE | 3 ml | Historical | ||||
| 0002-8214-05 | 00002821405 | 5 SYRINGE in 1 CARTON (0002-8214-05) / 3 mL in 1 SYRINGE (0002-8214-01) | 5 syringe | 2019-11-15 | 2026-07-27 | No | No | Current |