Byetta
- Product NDC
- 0310-6524
- 11-digit product format
- 003106524
- Labeler code
- 0310
- Product ID
- 0310-6524_7333a7dd-9449-4c61-b36d-c5d8d7cc239b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- exenatide
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA021773
- Marketing category
- NDA
- Marketing start
- 2014-12-12
- Marketing end
- 2026-11-30
- Substance
- EXENATIDE
- Active strength
- 250 ug/mL
- Pharmacologic classes
- GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Byetta
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EXENATIDE | 250 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9P1872D4OL |
| Rxcui | 847910, 847913, 847915, 847917 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0310-6524-01 | Byetta | 2.4 mL in 1 CARTRIDGE | INJECTION | 2.4 | | 26 |
| 0310-6524-01 | Byetta | 1 in 1 CARTON | INJECTION | 1 | | 26 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-6524 | BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP] | 24 | Current NDC, Legacy NDC, 2 package rows | 20241113_53d03c03-ebf7-418d-88a8-533eabd2ee4f.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 847913 | Byetta 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector | PSN | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847917 | Byetta 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector | PSN | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847910 | exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector | PSN | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847915 | exenatide 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector | PSN | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847917 | 60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector [Byetta] | SBD | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847913 | 60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector [Byetta] | SBD | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847915 | 60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector | SCD | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847910 | 60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector | SCD | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847917 | 60 ACTUAT Byetta 0.005 MG/ACTUAT Pen Injector | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847913 | 60 ACTUAT Byetta 0.01 MG/ACTUAT Pen Injector | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847913 | Byetta 10 MCG/ACTUAT Pen Injector, 60 ACTUAT | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847917 | Byetta 250 MCG/ML Pen Injector, 1.2 ML | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847913 | Byetta 250 MCG/ML Pen Injector, 2.4 ML | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847917 | Byetta 5 MCG/ACTUAT Pen Injector, 60 ACTUAT | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847910 | exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUAT | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847915 | exenatide 250 MCG/ML Pen Injector, 1.2 ML | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847910 | exenatide 250 MCG/ML Pen Injector, 2.4 ML | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
| 847915 | exenatide 5 MCG/ACTUAT Pen Injector, 60 ACTUAT | SY | 53d03c03-ebf7-418d-88a8-533eabd2ee4f | 26 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-6524-01 | 00310652401 | 1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE | 1 cartridge | 2014-12-12 | 2026-11-30 | No | No | Current |