exemestane

Generic: exemestane

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name exemestane
Generic Name exemestane
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

exemestane 25 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-383
Product ID 68382-383_25c7edf4-78c8-4acb-a49e-32e8c817b3e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202602
Listing Expiration 2026-12-31
Marketing Start 2018-10-08

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 68382383
Hyphenated Format 68382-383

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 ANDA202602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68382-383-06)
source: ndc

Packages (1)

68382-383-06 30 TABLET in 1 BOTTLE (68382-383-06)

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": "25c7edf4-78c8-4acb-a49e-32e8c817b3e9", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["NY22HMQ4BX"], "rxcui": ["310261"], "spl_set_id": ["f1bbe1bd-fa92-4fdd-88df-31ebcb200d37"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-383-06)", "package_ndc": "68382-383-06", "marketing_start_date": "20181008"}], "brand_name": "Exemestane", "product_id": "68382-383_25c7edf4-78c8-4acb-a49e-32e8c817b3e9", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "68382-383", "generic_name": "Exemestane", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exemestane", "active_ingredients": [{"name": "EXEMESTANE", "strength": "25 mg/1"}], "application_number": "ANDA202602", "marketing_category": "ANDA", "marketing_start_date": "20181008", "listing_expiration_date": "20261231"}