Exemestane
- Product NDC
- 68382-383
- 11-digit product format
- 683820383
- Labeler code
- 68382
- Product ID
- 68382-383_25c7edf4-78c8-4acb-a49e-32e8c817b3e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Exemestane
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202602
- Marketing category
- ANDA
- Marketing start
- 2018-10-08
- Substance
- EXEMESTANE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aromatase Inhibitor [EPC], Aromatase 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
- Exemestane
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EXEMESTANE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NY22HMQ4BX |
| Rxcui | 310261 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-383-06 | Exemestane | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-383 | EXEMESTANE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250103_f1bbe1bd-fa92-4fdd-88df-31ebcb200d37.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 |
|---|
| 68382-383-06 | 68382038306 | 30 TABLET in 1 BOTTLE (68382-383-06) | 30 tablet | 2018-10-08 | 0000-00-00 | No | No | Current |