BYDUREON BCise
- Product NDC
- 0310-6540
- 11-digit product format
- 003106540
- Labeler code
- 0310
- Product ID
- 0310-6540_5952c33f-0f0c-448e-bc90-98be65f123ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- exenatide
- Dosage form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- SUBCUTANEOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA209210
- Marketing category
- NDA
- Marketing start
- 2017-12-01
- Marketing end
- 0000-00-00
- Substance
- EXENATIDE
- Active strength
- 2 mg/.85mL
- Pharmacologic classes
- GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-6540 | BYDUREON BCISE (EXENATIDE) INJECTION, SUSPENSION, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 38 | Legacy NDC | 20241109_2d18cfc4-e0de-4814-a712-c1b7c504bff5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-6540-04 | 00310654004 | 4 CARTRIDGE in 1 CARTON (0310-6540-04) > .85 mL in 1 CARTRIDGE (0310-6540-01) | 4 cartridge | 2017-12-01 | 0000-00-00 | No | No | Current |
| 0310-6540-85 | 00310654085 | 1 CARTRIDGE in 1 CARTON (0310-6540-85) > .85 mL in 1 CARTRIDGE | 1 cartridge | 2017-12-01 | 0000-00-00 | Yes | No | Current |