Exemestane
- Product NDC
- 0054-0080
- 11-digit product format
- 000540080
- Labeler code
- 0054
- Product ID
- 0054-0080_76ca55bd-c459-4de7-8f26-33349ceb2462
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Exemestane
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc
- Application
- ANDA077431
- Marketing category
- ANDA
- Marketing start
- 2011-04-01
- Marketing end
- 0000-00-00
- Substance
- EXEMESTANE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| EXEMESTANE | ACTIVE INGREDIENT | NY22HMQ4BX | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| EXEMESTANE | ACTIVE MOIETY | NY22HMQ4BX | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | EXEMESTANE TABLET, FILM COATED [ROXANE LABORATORIES, INC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0080 | EXEMESTANE TABLET, FILM COATED [HIKMA PHARMACEUTICALS USA INC] | 11 | Legacy NDC | 20250110_2ecdb646-4d0f-4d1b-ac6a-9cb5deb9ac0d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0080-13 | 00054008013 | 30 TABLET, FILM COATED in 1 BOTTLE (0054-0080-13) | 2011-04-01 | 0000-00-00 | No | No | Current |