FDA.reportPublic FDA data

NDC 16729-034-01 - Letrozole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16729-034
Requested NDC
16729-034-01
Package NDCs from labels
16729-034-10, 16729-034-15, 16729-034-01, 16729-034-16, 16729-034-17, 16729-034-43
Manufacturer
A-S Medication Solutions
Effective date
2026-06-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Letrozole - A-S Medication SolutionsA-S Medication Solutions2026-06-22HUMAN PRESCRIPTION DRUG LABEL
Letrozole - Bryant Ranch PrepackBryant Ranch Prepack2026-04-03HUMAN PRESCRIPTION DRUG LABEL
Letrozole - Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd.Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd.2026-02-09HUMAN PRESCRIPTION DRUG LABEL
Letrozole - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2025-06-24HUMAN PRESCRIPTION DRUG LABEL
Letrozole - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-12-30HUMAN PRESCRIPTION DRUG LABEL
Letrozole - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-19HUMAN PRESCRIPTION DRUG LABEL
Letrozole - REMEDYREPACK INC.REMEDYREPACK INC.2019-11-05HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 73 of 138 · 2,756 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
unii: 15FIX9V2JP
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3ceb3368-439c-9f6c-e063-6294a90a98ba2025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cc8b151-c07d-7473-e063-6294a90a1cc72025-08-20WarningsExact identifier
unii: 15FIX9V2JP
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.