letrozole

Generic: letrozole

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name letrozole
Generic Name letrozole
Labeler atlantic biologicals corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

letrozole 2.5 mg/1

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0032
Product ID 17856-0032_38546ba0-8feb-9cf6-e063-6294a90a074c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090934
Listing Expiration 2026-12-31
Marketing Start 2020-01-13

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 178560032
Hyphenated Format 17856-0032

Supplemental Identifiers

RxCUI
200064
UNII
7LKK855W8I
NUI
N0000175563 N0000175080

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 letrozole (source: ndc)
Generic Name letrozole (source: ndc)
Application Number ANDA090934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (1)

17856-0032-1 100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCH

Ingredients (1)

letrozole (2.5 mg/1)

Linked Drug Pages (1)

Letrozole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38546ba0-8feb-9cf6-e063-6294a90a074c", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["7LKK855W8I"], "rxcui": ["200064"], "spl_set_id": ["c10bf97f-f9cf-468a-8a1f-7637f41022e4"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "17856-0032-1", "marketing_start_date": "20200113"}], "brand_name": "Letrozole", "product_id": "17856-0032_38546ba0-8feb-9cf6-e063-6294a90a074c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "17856-0032", "generic_name": "letrozole", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Letrozole", "active_ingredients": [{"name": "LETROZOLE", "strength": "2.5 mg/1"}], "application_number": "ANDA090934", "marketing_category": "ANDA", "marketing_start_date": "20200113", "listing_expiration_date": "20261231"}