SEMGLEE
- Product NDC
- 83257-012
- 11-digit product format
- 832570012
- Labeler code
- 83257
- Product ID
- 83257-012_3b749417-8933-850b-1373-990e7ee8a312
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- insulin glargine-yfgn
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Biocon Biologics Inc.
- Application
- BLA761201
- Marketing category
- BLA
- Marketing start
- 2023-07-28
- Marketing end
- 2027-05-31
- Substance
- INSULIN GLARGINE
- Active strength
- 100 [iU]/mL
- Pharmacologic classes
- Insulin Analog [EPC], Insulin [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 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 |
|---|---|---|---|---|---|---|
| 83257-012-31 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | 14 | |
| 83257-012-31 | SEMGLEE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 14 | |
| 83257-012-32 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | 14 | |
| 83257-012-32 | SEMGLEE | 3 in 1 CARTON | INJECTION, SOLUTION | 3 | 14 | |
| 83257-012-33 | SEMGLEE | 3 mL in 1 SYRINGE | INJECTION, SOLUTION | 3 | 14 | |
| 83257-012-33 | SEMGLEE | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83257-012-31 | ML - Milliliter | 83257-012 | 653afa7d-3a68-491f-bba7-58355f335579 | 1 | 2023-12-05 |
| 83257-012-33 | ML - Milliliter | 83257-012 | 3926f3bc-05a4-4fa4-a3cf-51896c184093 | 1 | 2023-12-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2563976 | insulin glargine-yfgn 100 UNT/ML Injectable Solution | PSN | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563971 | insulin glargine-yfgn 300 UNT in 3 ML Pen Injector | PSN | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563977 | Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable Solution | PSN | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563973 | Semglee (insulin glargine-yfgn) 300 UNT in 3 ML Pen Injector | PSN | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563973 | 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector [Semglee] | SBD | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563977 | insulin glargine-yfgn 100 UNT/ML Injectable Solution [Semglee] | SBD | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563971 | 3 ML insulin glargine-yfgn 100 UNT/ML Pen Injector | SCD | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563976 | insulin glargine-yfgn 100 UNT/ML Injectable Solution | SCD | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563971 | insulin glargine-yfgn 100 UNT/ML per 3 ML Pen Injector | SY | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563971 | insulin glargine-yfgn 300 UNT per 3 ML Pen Injector | SY | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563977 | Semglee (insulin glargine-yfgn) 100 UNT/ML Injectable Solution | SY | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563973 | Semglee (insulin glargine-yfgn) 100 UNT/ML per 3 ML Pen Injector | SY | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
| 2563973 | Semglee (insulin glargine-yfgn) 300 UNT per 3 ML Pen Injector | SY | 8cf5544f-87d6-468b-f6ae-898b1fdb5d80 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 83257-012-31 | 83257001231 | 1 SYRINGE in 1 CARTON (83257-012-31) / 3 mL in 1 SYRINGE | 1 syringe | 2023-07-28 | 2027-05-31 | No | No | Historical |
| 83257-012-32 | 83257001232 | 3 mL in 1 SYRINGE | 3 ml | Historical | ||||
| 83257-012-33 | 83257001233 | 5 SYRINGE in 1 CARTON (83257-012-33) / 3 mL in 1 SYRINGE | 5 syringe | 2023-07-28 | 2027-05-31 | No | No | Historical |