KAZANO
- Product NDC
- 64764-335
- 11-digit product format
- 647640335
- Labeler code
- 64764
- Product ID
- 64764-335_2179e953-e16e-4bfe-a36e-fce2da468f33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alogliptin and metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA203414
- Marketing category
- NDA
- Marketing start
- 2013-01-25
- Substance
- ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
- Active strength
- 12.5; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KAZANO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALOGLIPTIN BENZOATE | 12.5 mg/1 |
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E, EEN99869SC |
| Rxcui | 1368385, 1368391, 1368392, 1368398 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64764-335-01 | KAZANO | 4 in 1 TRAY | TABLET, FILM COATED | 4 | | 21 |
| 64764-335-01 | KAZANO | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 21 |
| 64764-335-60 | KAZANO | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 21 |
| 64764-335-77 | KAZANO | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 21 |
| 64764-335-80 | KAZANO | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALOGLIPTIN BENZOATE | ACTIVE INGREDIENT | EEN99869SC | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| Metformin hydrochloride | ACTIVE INGREDIENT | 786Z46389E | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| Alogliptin | ACTIVE MOIETY | JHC049LO86 | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| Metformin | ACTIVE MOIETY | 9100L32L2N | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64764-335 | KAZANO (ALOGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] | 20 | Current NDC, Legacy NDC, 5 package rows | 20250302_83cb7914-a683-47bb-a713-f2bc6a596bd2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64764-335-01 | 64764033501 | 4 CARTON in 1 TRAY (64764-335-01) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK | 4 carton | 2013-01-25 | 0000-00-00 | No | No | Current |
| 64764-335-60 | 64764033560 | 60 TABLET, FILM COATED in 1 BOTTLE (64764-335-60) | | 2013-01-25 | 0000-00-00 | No | No | Current |
| 64764-335-77 | 64764033577 | 500 TABLET, FILM COATED in 1 BOTTLE (64764-335-77) | | 2013-01-25 | 0000-00-00 | No | No | Current |
| 64764-335-80 | 64764033580 | 180 TABLET, FILM COATED in 1 BOTTLE (64764-335-80) | | 2013-01-25 | 0000-00-00 | No | No | Current |