FDA.reportPublic FDA data

Femara

Product NDC
0078-0249
11-digit product format
000780249
Labeler code
0078
Product ID
0078-0249_f052c25a-d848-4b2d-8ff3-73bee0c89ad7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020726
Marketing category
NDA
Marketing start
1997-07-31
Substance
LETROZOLE
Active strength
2.5 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LETROZOLE2.5 mg/1

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
0078-0249-15Femara30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0249-15EA - Each0078-0249caa3e001-9ec4-457d-b930-5163d06ba6ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8IFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
LETROZOLEACTIVE MOIETY7LKK855W8IFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
TALCINACTIVE INGREDIENT7SEV7J4R1UFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]16
LETROZOLEACTIVE INGREDIENT7LKK855W8IFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LETROZOLEACTIVE MOIETY7LKK855W8IFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0249FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]29Current NDC, Legacy NDC, 1 package rows20241222_82b77d74-085f-45ac-a7dd-1f5c038bf406.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153124Femara 2.5 MG Oral TabletPSN82b77d74-085f-45ac-a7dd-1f5c038bf40631
200064letrozole 2.5 MG Oral TabletPSN82b77d74-085f-45ac-a7dd-1f5c038bf40631
153124letrozole 2.5 MG Oral Tablet [Femara]SBD82b77d74-085f-45ac-a7dd-1f5c038bf40631
200064letrozole 2.5 MG Oral TabletSCD82b77d74-085f-45ac-a7dd-1f5c038bf40631
153124Femara 2.5 MG Oral TabletSY82b77d74-085f-45ac-a7dd-1f5c038bf40631
153124Femara 2.5 MG Oral TabletPSNe11b0a54-92bd-4790-8b80-f439f7093c012
200064letrozole 2.5 MG Oral TabletPSNe11b0a54-92bd-4790-8b80-f439f7093c012
153124letrozole 2.5 MG Oral Tablet [Femara]SBDe11b0a54-92bd-4790-8b80-f439f7093c012
200064letrozole 2.5 MG Oral TabletSCDe11b0a54-92bd-4790-8b80-f439f7093c012
153124Femara 2.5 MG Oral TabletSYe11b0a54-92bd-4790-8b80-f439f7093c012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0249-150007802491530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15) 1997-07-310000-00-00NoNoCurrent