Sovaldi
- Product NDC
- 61958-1503
- 11-digit product format
- 619581503
- Labeler code
- 61958
- Product ID
- 61958-1503_74c52ec6-8358-4e63-b299-64ec1ff7f434
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SOFOSBUVIR
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc.
- Application
- NDA204671
- Marketing category
- NDA
- Marketing start
- 2019-08-28
- Substance
- SOFOSBUVIR
- Active strength
- 200 mg/1
- Pharmacologic classes
- Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], RNA Replicase 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
- Sovaldi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOFOSBUVIR | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WJ6CA3ZU8B |
| Rxcui | 1484916, 1484922, 2203891, 2203893, 2203993, 2203999, 2204090, 2204092 |
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 |
|---|
| 61958-1503-1 | Sovaldi | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SOFOSBUVIR | ACTIVE INGREDIENT | WJ6CA3ZU8B | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| SOFOSBUVIR | ACTIVE MOIETY | WJ6CA3ZU8B | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61958-1503 | SOVALDI (SOFOSBUVIR) TABLET, FILM COATED SOVALDI (SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC.] | 16 | Current NDC, Legacy NDC, 1 package rows | 20250112_80beab2c-396e-4a37-a4dc-40fdb62859cf.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 |
|---|
| 61958-1503-1 | 61958150301 | 28 TABLET, FILM COATED in 1 BOTTLE (61958-1503-1) | 2019-08-28 | 0000-00-00 | No | No | Current |