exemestane

Generic: exemestane

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name exemestane
Generic Name exemestane
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

exemestane 25 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-005
Product ID 51991-005_cb46b87b-4bbc-4aed-8656-877a480061af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211031
Listing Expiration 2026-12-31
Marketing Start 2019-12-19

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 51991005
Hyphenated Format 51991-005

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 ANDA211031 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)
source: ndc

Packages (1)

51991-005-90 90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)

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": "cb46b87b-4bbc-4aed-8656-877a480061af", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["NY22HMQ4BX"], "rxcui": ["310261"], "spl_set_id": ["4e3fd382-19f5-4ded-ab22-39d5b1b2f366"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)", "package_ndc": "51991-005-90", "marketing_start_date": "20201115"}], "brand_name": "Exemestane", "product_id": "51991-005_cb46b87b-4bbc-4aed-8656-877a480061af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "51991-005", "generic_name": "Exemestane", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exemestane", "active_ingredients": [{"name": "EXEMESTANE", "strength": "25 mg/1"}], "application_number": "ANDA211031", "marketing_category": "ANDA", "marketing_start_date": "20191219", "listing_expiration_date": "20261231"}