Letrozole

Product NDC
17856-0032
11-digit product format
178560032
Labeler code
17856
Product ID
17856-0032_38546ba0-8feb-9cf6-e063-6294a90a074c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA090934
Marketing category
ANDA
Marketing start
2020-01-13
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0032-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0032-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0032-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0032-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0032-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0032-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0032-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0032-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0032-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0032-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0032-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0032-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0032-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0032-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0032-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0032-1bd6a592717d7…303034d00443…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090934-001LETROZOLELETROZOLE2.5MGTABLET / 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
A090934-001AB

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-033f01610625f2…
2019-09-15 20:21 UTC2019-09A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090934-001LETROZOLE2.5MGTABLET / ORALAB2011-06-03e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090934-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090934-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090934-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090934-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090934-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090934-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090934-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090934-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090934-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090934-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090934-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090934-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090934-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090934-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090934-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090934-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090934-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090934-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090934-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090934-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090934-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090934-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090934-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090934-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090934-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090934-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090934-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090934-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090934-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090934-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090934-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090934-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090934-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090934-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090934-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090934-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090934-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090934-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090934-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090934-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Letrozole
Listing expiration
2026-12-31

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
c10bf97f-f9cf-468a-8a1f-7637f41022e4Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0032-1Letrozole1 in 1 POUCHTABLET, FILM COATED13
17856-0032-1Letrozole100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0032LETROZOLE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 2 package rows20250412_c10bf97f-f9cf-468a-8a1f-7637f41022e4.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LetrozoleLETROZOLEA-S Medication Solutions065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
LetrozoleLETROZOLEBryant Ranch Prepack26dcb6ee-74d8-4804-b151-79a41484979b2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
LetrozoleLETROZOLEAccord Healthcare, Inc.c391fe11-fd47-4a35-af6d-c823ab7b88382026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
LetrozoleLETROZOLEATLANTIC BIOLOGICALS CORP.c10bf97f-f9cf-468a-8a1f-7637f41022e42025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
ndc (product): 17856-0032
LetrozoleLETROZOLENuCare Pharmaceuticals,Inc.a707ec4b-8d26-55c2-e053-2a95a90a2e072024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
LetrozoleLETROZOLENuCare Pharmaceuticals,Inc.1b408ba8-05f7-1cf1-e063-6394a90a42bc2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200064letrozole 2.5 MG Oral TabletPSNc10bf97f-f9cf-468a-8a1f-7637f41022e43
200064letrozole 2.5 MG Oral TabletSCDc10bf97f-f9cf-468a-8a1f-7637f41022e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0032-117856003201100 POUCH in 1 BOX, UNIT-DOSE (17856-0032-1) / 1 TABLET, FILM COATED in 1 POUCH100 pouch2020-01-130000-00-00NoNoCurrent