ERIVEDGE
- Product NDC
- 50242-140
- 11-digit product format
- 502420140
- Labeler code
- 50242
- Product ID
- 50242-140_d8b343ee-5767-4934-ad68-5164d4de5228
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vismodegib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Genentech, Inc.
- Application
- NDA203388
- Marketing category
- NDA
- Marketing start
- 2012-01-30
- Substance
- VISMODEGIB
- Active strength
- 150 mg/1
- Pharmacologic classes
- Hedgehog Pathway Inhibitor [EPC], Smoothened Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ERIVEDGE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VISMODEGIB | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 25X868M3DS |
| Rxcui | 1242992, 1242998 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-140-01 | ERIVEDGE | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 15 |
| 50242-140-01 | ERIVEDGE | 1 in 1 CARTON | CAPSULE | 1 | | 15 |
| 50242-140-86 | ERIVEDGE | 1 in 1 CARTON | CAPSULE | 1 | | 15 |
| 50242-140-86 | ERIVEDGE | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| vismodegib | ACTIVE INGREDIENT | 25X868M3DS | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| vismodegib | ACTIVE MOIETY | 25X868M3DS | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| povidone K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-140 | ERIVEDGE (VISMODEGIB) CAPSULE [GENENTECH, INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20241210_eb368bb6-80e3-4df9-8a85-91df0a2ada6a.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 |
|---|
| 50242-140-01 | 50242014001 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2012-01-30 | 0000-00-00 | No | No | Current |
| 50242-140-86 | 50242014086 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC | 2013-04-09 | 0000-00-00 | Yes | No | Current |