QTERN
- Product NDC
- 0310-6770
- 11-digit product format
- 003106770
- Labeler code
- 0310
- Product ID
- 0310-6770_702d38dd-1db2-4452-824c-1410452ec672
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dapagliflozin and saxagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA209091
- Marketing category
- NDA
- Marketing start
- 2017-12-04
- Marketing end
- 0000-00-00
- Substance
- DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-6770 | QTERN (DAPAGLIFLOZIN AND SAXAGLIPTIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] | 31 | Legacy NDC | 20241116_423c489c-085b-4320-b892-7868ebd6dc6b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-6770-30 | 00310677030 | 30 TABLET, FILM COATED in 1 BOTTLE (0310-6770-30) | 2019-06-17 | 0000-00-00 | No | No | Current |
| 0310-6770-95 | 00310677095 | 7 TABLET, FILM COATED in 1 BLISTER PACK (0310-6770-95) | 2019-07-01 | 0000-00-00 | No | No | Current |