JANUVIA
- Product NDC
- 55154-5040
- 11-digit product format
- 551545040
- Labeler code
- 55154
- Product ID
- 55154-5040_f843c4d2-5112-42bf-b060-ed74648d922e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sitagliptin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- NDA021995
- Marketing category
- NDA
- Marketing start
- 2006-10-16
- Substance
- SITAGLIPTIN PHOSPHATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- 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
- JANUVIA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SITAGLIPTIN PHOSPHATE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TS63EW8X6F |
| Rxcui | 665044, 2709608 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-5040-8 | JANUVIA | 2340 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 2340 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SITAGLIPTIN PHOSPHATE | ACTIVE INGREDIENT | TS63EW8X6F | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| SITAGLIPTIN | ACTIVE MOIETY | QFP0P1DV7Z | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-5040 | JANUVIA (SITAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] | 25 | Current NDC, Legacy NDC, 1 package rows | 20240928_39253ddd-0245-43b1-ad28-d5923983afb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-5040-8 | 55154504008 | 2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8) | 2006-10-16 | 0000-00-00 | No | No | Current |