Zydelig
- Product NDC
- 61958-1701
- 11-digit product format
- 619581701
- Labeler code
- 61958
- Product ID
- 61958-1701_ca3e7112-6dfe-403f-af6f-a0051e77d125
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- idelalisib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA205858
- Marketing category
- NDA
- Marketing start
- 2014-07-23
- Substance
- IDELALISIB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], 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
- Zydelig
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IDELALISIB | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | YG57I8T5M0 |
| Rxcui | 1544465, 1544471, 1544473, 1544475 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61958-1701-1 | Zydelig | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IDELALISIB | ACTIVE INGREDIENT | YG57I8T5M0 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| IDELALISIB | ACTIVE MOIETY | YG57I8T5M0 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61958-1701 | ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250223_efbdafa9-d18c-4e85-b4a2-1e620fc74e50.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 |
|---|
| 61958-1701-1 | 61958170101 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1) | 2014-07-23 | 0000-00-00 | No | No | Current |