KOMBIGLYZE
- Product NDC
- 0310-6135
- 11-digit product format
- 003106135
- Labeler code
- 0310
- Product ID
- 0310-6135_f2b2e5cb-8544-4aae-a3b6-96c8517dab61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- NDA200678
- Marketing category
- NDA
- Marketing start
- 2014-12-04
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
- Active strength
- 500 mg/1; mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| metformin hydrochloride | ACTIVE INGREDIENT | 786Z46389E | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| saxagliptin hydrochloride | ACTIVE INGREDIENT | Z8J84YIX6L | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| metformin | ACTIVE MOIETY | 9100L32L2N | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| saxagliptin anhydrous | ACTIVE MOIETY | 8I7IO46IVQ | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| hypromellose 2208 (15000 mpa.s) | INACTIVE INGREDIENT | Z78RG6M2N2 | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0310-6135 | KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ASTRAZENECA PHARMACEUTICALS LP] | 23 | Legacy NDC | 20241020_fbd25da4-ebe6-45c9-beb8-93523d11a0b4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0310-6135-30 | 00310613530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6135-30) | | 2015-01-01 | 0000-00-00 | No | No | Current |
| 0310-6135-95 | 00310613595 | 1 BLISTER PACK in 1 CARTON (0310-6135-95) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2015-01-01 | 0000-00-00 | Yes | No | Current |