JANUMET
- Product NDC
- 0006-0575
- 11-digit product format
- 000060575
- Labeler code
- 0006
- Product ID
- 0006-0575_601dfad8-02f7-4696-9fe2-548610338dc9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SITAGLIPTIN and METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA022044
- Marketing category
- NDA
- Marketing start
- 2007-03-30
- Substance
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
- Active strength
- 500; 50 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
- JANUMET
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
| SITAGLIPTIN PHOSPHATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TS63EW8X6F, 786Z46389E |
| Rxcui | 861771, 861821, 2709488, 2709491 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0006-0575-01 | JANUMET | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 60 |
| 0006-0575-02 | JANUMET | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 60 |
| 0006-0575-03 | JANUMET | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 60 |
| 0006-0575-52 | JANUMET | 5 in 1 CARTON | TABLET, FILM COATED | 5 | | 60 |
| 0006-0575-56 | JANUMET | 4 in 1 CARTON | TABLET, FILM COATED | 4 | | 60 |
| 0006-0575-56 | JANUMET | 2 in 1 POUCH | TABLET, FILM COATED | 2 | | 60 |
| 0006-0575-61 | JANUMET | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 60 |
| 0006-0575-62 | JANUMET | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 60 |
| 0006-0575-82 | JANUMET | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 60 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| SITAGLIPTIN PHOSPHATE | ACTIVE INGREDIENT | TS63EW8X6F | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| SITAGLIPTIN | ACTIVE MOIETY | QFP0P1DV7Z | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | 33 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0006-0575 | JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] | 60 | Current NDC, Legacy NDC, 9 package rows | 20250331_d19c7ed0-ad5c-426e-b2df-722508f97d67.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 |
|---|
| 0006-0575-01 | 00006057501 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 0006-0575-02 | 00006057502 | 14 in 1 BOTTLE | | | | | | Historical |
| 0006-0575-03 | 00006057503 | 2 BOTTLE in 1 CARTON (0006-0575-03) / 14 TABLET, FILM COATED in 1 BOTTLE (0006-0575-02) | 2 bottle | 2007-03-30 | 0000-00-00 | Yes | No | Current |
| 0006-0575-52 | 00006057552 | 5 in 1 CARTON | | | | | | Historical |
| 0006-0575-56 | 00006057556 | 4 POUCH in 1 CARTON (0006-0575-56) / 2 BLISTER PACK in 1 POUCH / 7 TABLET, FILM COATED in 1 BLISTER PACK | 4 pouch | 2007-03-30 | 0000-00-00 | Yes | No | Current |
| 0006-0575-61 | 00006057561 | 60 TABLET, FILM COATED in 1 BOTTLE (0006-0575-61) | | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0006-0575-62 | 00006057562 | 180 TABLET, FILM COATED in 1 BOTTLE (0006-0575-62) | | 2007-03-30 | 0000-00-00 | No | No | Current |
| 0006-0575-82 | 00006057582 | 1000 TABLET, FILM COATED in 1 BOTTLE (0006-0575-82) | | 2007-03-30 | 0000-00-00 | No | No | Current |