ADDYI
- Product NDC
- 58604-214
- 11-digit product format
- 586040214
- Labeler code
- 58604
- Product ID
- 58604-214_1d1d7ef0-7a05-41c3-849f-6f1778863a73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- flibanserin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sprout Pharmaceuticals, Inc.
- Application
- NDA022526
- Marketing category
- NDA
- Marketing start
- 2015-08-18
- Substance
- FLIBANSERIN
- Active strength
- 100 mg/1
- Pharmacologic classes
- P-Glycoprotein 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
- ADDYI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLIBANSERIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 37JK4STR6Z |
| Rxcui | 1665514, 1666391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58604-214-03 | ADDYI | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 58604-214-03 | ADDYI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 15 |
| 58604-214-30 | ADDYI | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 58604-214-30 | ADDYI | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Flibanserin | ACTIVE INGREDIENT | 37JK4STR6Z | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Flibanserin | ACTIVE MOIETY | 37JK4STR6Z | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Lactose Monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Polyethylene Glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58604-214 | ADDYI (FLIBANSERIN) TABLET, FILM COATED [SPROUT PHARMACEUTICALS, INC.] | 14 | Current NDC, Legacy NDC, 4 package rows | 20250321_3819daf3-e935-2c53-c527-e1d57922f394.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 |
|---|
| 58604-214-03 | 58604021403 | 30 in 1 BOTTLE | | | | | | Historical |
| 58604-214-30 | 58604021430 | 1 BOTTLE in 1 CARTON (58604-214-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-08-18 | 0000-00-00 | No | No | Current |