FDA.reportPublic FDA data

NDC 69339-160-01 - Megestrol Acetate

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
69339-160
Requested NDC
69339-160-01
Package NDCs from labels
69339-160-01, 69339-160-16, 69339-160-17, 69339-160-18, 69339-160-19
Manufacturer
Natco Pharma USA LLC | Strides Pharma, Inc
Effective date
2026-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Megestrol Acetate - Natco Pharma USA LLC | Strides Pharma, IncNatco Pharma USA LLC | Strides Pharma, Inc2026-01-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
69339-160-16MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-17MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-18MEGESTROL ACETATE ORAL SUSPENSION, USP
69339-160-19MEGESTROL ACETATE ORAL SUSPENSION, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-160-01Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
69339-160-16Megestrol Acetate3 in 1 CASESUSPENSION32
69339-160-16Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-17Megestrol Acetate4 in 1 CASESUSPENSION42
69339-160-17Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate10 in 1 TRAYSUSPENSION102
69339-160-18Megestrol Acetate5 in 1 CASESUSPENSION52
69339-160-19Megestrol Acetate10 in 1 CASESUSPENSION102
69339-160-19Megestrol Acetate10 in 1 TRAYSUSPENSION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-160MEGESTROL ACETATE SUSPENSION [NATCO PHARMA USA LLC]1Current NDC, 9 package rows20230825_582cff8a-1def-43d6-ba7e-dce49e3e9f27.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-160-01ML - Milliliter69339-16067edb6da-5e2c-4fcc-8a4a-3b098aaff6eb12023-09-05
69339-160-16ML - Milliliter69339-16027f6e6c7-08d3-442e-b959-3a663f18545312023-09-05
69339-160-17ML - Milliliter69339-16031b3dcc7-2913-4c24-b3a6-640158ec6c3712023-09-05
69339-160-18ML - Milliliter69339-16059fcc138-63c5-45d5-b946-93f453f5505612023-09-05
69339-160-19ML - Milliliter69339-160da7e552a-6eec-4c7f-993b-b3d609d66d9912023-09-05

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 38 of 39 · 767 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: PDC6A3C0OX
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
unii: 1Q73Q2JULR
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited9f7365a0-67cf-45fc-a914-e40a4507a0632022-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA075671
ndc (product): 64380-160
rxcui: 860225
spl id: d842f1ed-8df5-4fe9-a694-5da7a042134e
spl set id: 9f7365a0-67cf-45fc-a914-e40a4507a063
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEProficient Rx LP6342df31-afce-4deb-b992-e08e2a4b2b772022-04-01Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
unii: F05Q2T2JA0
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
unii: F05Q2T2JA0
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9a61f1ae-d3a4-68d7-e053-2a95a90a43332020-12-03WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9aefc830-329c-5e35-e053-2a95a90a6ffe2020-11-30WarningsExact identifier
unii: C151H8M554
Food AdditivesIRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,Newton Laboratories, Inc.9af2d6f4-baa8-5da9-e053-2995a90a3dac2020-11-30WarningsExact identifier
unii: C151H8M554
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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