Letrozole

Product NDC
16729-034
11-digit product format
167290034
Labeler code
16729
Product ID
16729-034_4a681bf4-9779-a1b2-e063-6294a90a83db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
letrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA090934
Marketing category
ANDA
Marketing start
2011-06-02
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 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
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
c391fe11-fd47-4a35-af6d-c823ab7b8838Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d50ad188-a2a9-1aec-5d6c-f8612e9e5867Product name420190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083Product name220170713

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-034-01Letrozole100 in 1 BOTTLETABLET, FILM COATED10013
16729-034-10Letrozole30 in 1 BOTTLETABLET, FILM COATED3013
16729-034-15Letrozole90 in 1 BOTTLETABLET, FILM COATED9013
16729-034-16Letrozole500 in 1 BOTTLETABLET, FILM COATED50013
16729-034-17Letrozole1000 in 1 BOTTLETABLET, FILM COATED100013
16729-034-43Letrozole100 in 1 CARTONTABLET, FILM COATED10013
16729-034-43Letrozole10 in 1 BLISTER PACKTABLET, FILM COATED1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-034-10EA - Each16729-034cebea3e0-335d-4007-80f9-f6d512b2433012012-07-24
16729-034-15EA - Each16729-034635a5fa4-55cd-4b88-8edd-92b09fca7d6a12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LETROZOLEACTIVE INGREDIENT7LKK855W8ILETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
LETROZOLEACTIVE MOIETY7LKK855W8ILETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-034LETROZOLE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]12Current NDC, Legacy NDC, 7 package rows20250524_c391fe11-fd47-4a35-af6d-c823ab7b8838.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
ndc (product): 16729-034
LetrozoleLETROZOLEATLANTIC BIOLOGICALS CORP.c10bf97f-f9cf-468a-8a1f-7637f41022e42025-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090934
application number: ANDA090934
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 TabletPSNc391fe11-fd47-4a35-af6d-c823ab7b883813
200064letrozole 2.5 MG Oral TabletSCDc391fe11-fd47-4a35-af6d-c823ab7b883813
200064letrozole 2.5 MG Oral TabletPSN065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c9
200064letrozole 2.5 MG Oral TabletPSN26dcb6ee-74d8-4804-b151-79a41484979b9
200064letrozole 2.5 MG Oral TabletSCD065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c9
200064letrozole 2.5 MG Oral TabletSCD26dcb6ee-74d8-4804-b151-79a41484979b9
200064letrozole 2.5 MG Oral TabletPSNa707ec4b-8d26-55c2-e053-2a95a90a2e074
200064letrozole 2.5 MG Oral TabletSCDa707ec4b-8d26-55c2-e053-2a95a90a2e074
200064letrozole 2.5 MG Oral TabletPSNc10bf97f-f9cf-468a-8a1f-7637f41022e43
200064letrozole 2.5 MG Oral TabletSCDc10bf97f-f9cf-468a-8a1f-7637f41022e43
200064letrozole 2.5 MG Oral TabletPSN1b408ba8-05f7-1cf1-e063-6394a90a42bc1
200064letrozole 2.5 MG Oral TabletSCD1b408ba8-05f7-1cf1-e063-6394a90a42bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-034-0116729003401100 in 1 BOTTLEHistorical
16729-034-101672900341030 TABLET, FILM COATED in 1 BOTTLE (16729-034-10) 2011-06-020000-00-00NoNoCurrent
16729-034-151672900341590 TABLET, FILM COATED in 1 BOTTLE (16729-034-15) 2014-12-310000-00-00NoNoCurrent
16729-034-1616729003416500 in 1 BOTTLEHistorical
16729-034-17167290034171000 in 1 BOTTLEHistorical
16729-034-4316729003443100 in 1 CARTONHistorical