SPRYCEL
- Product NDC
- 0003-0528
- 11-digit product format
- 000030528
- Labeler code
- 0003
- Product ID
- 0003-0528_8f0a3afc-dde4-40d1-941d-68efd3f62adc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dasatinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA021986
- Marketing category
- NDA
- Marketing start
- 2006-06-27
- Substance
- DASATINIB
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase 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
- SPRYCEL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DASATINIB | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RBZ1571X5H |
| Rxcui | 643105, 643107, 643109, 643173, 643175, 643177, 799047, 799830, 1045402, 1045404, 1045406, 1045408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-0528-11 | SPRYCEL | 60 in 1 BOTTLE | TABLET | 60 | | 47 |
| 0003-0528-11 | SPRYCEL | 1 in 1 CARTON | TABLET | 1 | | 47 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| dasatinib | ACTIVE INGREDIENT | RBZ1571X5H | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| dasatinib anhydrous | ACTIVE MOIETY | X78UG0A0RN | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 30 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-0528 | SPRYCEL (DASATINIB) TABLET [E.R. SQUIBB & SONS, L.L.C.] | 47 | Current NDC, Legacy NDC, 2 package rows | 20240815_4764f37b-c9e6-4ede-bcc2-8a03b7c521df.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 |
|---|
| 0003-0528-11 | 00003052811 | 1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLE | 1 bottle | 2006-06-27 | 0000-00-00 | No | No | Current |