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 18 of 138 · 2,756 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING NON-TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b946c39-718b-d70e-e063-6394a90a0db82026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Outdoor AllergiesACONITUM NAPELLUS, ADRENALINUM, ALLIUM CEPA, RAGWEED POLLEN, ARSENICUM IODATUM, MUGWORT POLLEN, MUSTARD POLLEN, LAMBS QUARTERS POLLEN, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS POLLEN, ALFALFA POLLEN, TIMOTHY GRASS POLLEN, YELLOW DOCK POLLEN, SABADILLA, SILICEA, DANDELION POLLEN, RED CLOVER POLLEN, COCKLEBUR POLLENNaturalCareb0a76faa-a081-4cee-ae40-e5605458bec32026-02-23WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: ETJ7Z6XBU4
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
LetrozoleLETROZOLEAccord Healthcare, Inc.c391fe11-fd47-4a35-af6d-c823ab7b88382026-02-09Warnings, Adverse reactionsExact identifier
application number: ANDA090934
ndc (package): 16729-034-01
ndc (package): 16729-034-43
ndc (package): 16729-034-17
ndc (package): 16729-034-10
ndc (package): 16729-034-15
ndc (package): 16729-034-16
ndc (product): 16729-034
ndc11 (package): 16729003401
rxcui: 200064
spl id: 4a681bf4-9779-a1b2-e063-6294a90a83db
spl set id: c391fe11-fd47-4a35-af6d-c823ab7b8838
unii: 7LKK855W8I
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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