exemestane

Generic: exemestane

Labeler: upsher-smith laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name exemestane
Generic Name exemestane
Labeler upsher-smith laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

exemestane 25 mg/1

Manufacturer
Upsher-Smith Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0832-0595
Product ID 0832-0595_2f12eda2-6bae-041a-e063-6294a90ac968
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209208
Listing Expiration 2026-12-31
Marketing Start 2017-07-27

Pharmacologic Class

Established (EPC)
aromatase inhibitor [epc]
Mechanism of Action
aromatase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08320595
Hyphenated Format 0832-0595

Supplemental Identifiers

RxCUI
310261
UNII
NY22HMQ4BX
NUI
N0000175563 N0000175080

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name exemestane (source: ndc)
Generic Name exemestane (source: ndc)
Application Number ANDA209208 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0832-0595-30)
source: ndc

Packages (1)

0832-0595-30 30 TABLET in 1 BOTTLE (0832-0595-30)

Ingredients (1)

exemestane (25 mg/1)

Linked Drug Pages (1)

Exemestane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f12eda2-6bae-041a-e063-6294a90ac968", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["NY22HMQ4BX"], "rxcui": ["310261"], "spl_set_id": ["f8bd17b4-5289-45bb-8095-de89dc8d39ed"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0832-0595-30)", "package_ndc": "0832-0595-30", "marketing_start_date": "20170727"}], "brand_name": "Exemestane", "product_id": "0832-0595_2f12eda2-6bae-041a-e063-6294a90ac968", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "0832-0595", "generic_name": "Exemestane", "labeler_name": "Upsher-Smith Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exemestane", "active_ingredients": [{"name": "EXEMESTANE", "strength": "25 mg/1"}], "application_number": "ANDA209208", "marketing_category": "ANDA", "marketing_start_date": "20170727", "listing_expiration_date": "20261231"}