FDA.reportPublic FDA data

LETROZOLE

Product NDC
50268-476
Requested package NDC
50268-476-15
11-digit product format
502680476
Labeler code
50268
Product ID
50268-476_48d4cf4a-83a7-4e5f-e063-6394a90a4ece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LETROZOLE
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA200161
Marketing category
ANDA
Marketing start
2019-10-02
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200161-001LETROZOLELETROZOLE2.5MGTABLET / ORALAB2011-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A200161-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200161-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200161-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LETROZOLELETROZOLEBreckenridge Pharmaceutical, Inc.63e54b62-a30d-4a56-9215-75e7a0b0bf022026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200161
application number: ANDA200161
LETROZOLELETROZOLEA-S Medication Solutions3baa3912-3e64-473b-8ec6-8557aa7907c22026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200161
application number: ANDA200161
LETROZOLELETROZOLEAvPAK93f317f1-96d1-498e-e053-2995a90ac60d2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200161
application number: ANDA200161
ndc (package): 50268-476-15
ndc (product): 50268-476
ndc11 (package): 50268047615
LETROZOLELETROZOLEBryant Ranch Prepack3cc750a5-cc88-4b42-b4ab-a87e760f291d2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200161
application number: ANDA200161
LetrozoleLETROZOLENatco Pharma Limited35c73219-c39e-4e10-b944-76009b061e792020-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200161
application number: ANDA200161

Additional Listing Data#

Finished product
Yes
Brand name base
LETROZOLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LETROZOLE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7LKK855W8IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200064Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
93f317f1-96d1-498e-e053-2995a90ac60dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-476-11LETROZOLE1 in 1 BLISTER PACKTABLET15
50268-476-15LETROZOLE50 in 1 BOXTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-476-11EA - Each50268-476ea96e760-0007-4407-adc2-d155e9dda7e812019-11-12
50268-476-15EA - Each50268-4763722763c-54ff-4338-9b55-6d9098fe2b0112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-476LETROZOLE TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_93f317f1-96d1-498e-e053-2995a90ac60d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSN93f317f1-96d1-498e-e053-2995a90ac60d5
200064letrozole 2.5 MG Oral TabletSCD93f317f1-96d1-498e-e053-2995a90ac60d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-476-155026804761550 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11) 50 blister pack2019-10-020000-00-00NoNoCurrent