Home NDC 0078-0249 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020726-001 FEMARA LETROZOLE 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020726-001 AB
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020726-001 FEMARA 2.5MG TABLET / ORAL AB RLD, RS 1997-07-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Femara
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LETROZOLE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7LKK855W8I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153124 Internal RxNorm lookup 200064 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0249-15 Femara 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LETROZOLE ACTIVE INGREDIENT 7LKK855W8I FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 LETROZOLE ACTIVE MOIETY 7LKK855W8I FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 TALC INACTIVE INGREDIENT 7SEV7J4R1U FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 16 LETROZOLE ACTIVE INGREDIENT 7LKK855W8I FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 LETROZOLE ACTIVE MOIETY 7LKK855W8I FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FEMARA (LETROZOLE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0249 FEMARA (LETROZOLE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 29 Current NDC, Legacy NDC, 1 package rows 20241222_82b77d74-085f-45ac-a7dd-1f5c038bf406.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Femara LETROZOLE Novartis Pharmaceuticals Corporation 82b77d74-085f-45ac-a7dd-1f5c038bf406 2026-06-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 020726 application number: NDA020726 ndc (product): 0078-0249
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0249-15 00078024915 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15) 1997-07-31 0000-00-00 No No Current