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 32 of 39 · 767 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.bf0d54c5-b813-4f2e-9a37-cbea332cfe532024-03-28Warnings, Adverse reactionsExact identifier
application number: ANDA075671
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.d0ad931e-4e3e-48bf-9949-77d6971da6e62024-03-28Warnings, Adverse reactionsExact identifier
application number: ANDA075671
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEANI Pharmaceuticals, Inc.a26dcd78-ad62-4cf5-ad97-49ccb34d43ba2024-03-20Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)89dc2063-6744-4412-89be-90990090b57c2024-03-19WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)dcab26ff-2c10-4478-90a8-c89d87261bfa2024-03-19WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)4d1391da-7874-4a51-a468-2843ecf6f92b2024-03-18WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)adaea845-e029-422d-a947-d8ce8f5787ed2024-03-18WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)8b033d56-b95b-4905-9f33-cf2fbd61ce352024-03-15WarningsExact identifier
unii: F05Q2T2JA0
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.7e3a254b-a43d-43a2-a777-0d0c0057e1312024-03-14WarningsExact identifier
unii: C151H8M554
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCVS Pharmacy6a97a181-1ec2-473d-a588-db2f2f2f662d2024-03-14WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacydcd27653-4c81-4630-a8b7-5fb5dc3e976a2024-03-13WarningsExact identifier
unii: F05Q2T2JA0
Laxative Stool SoftenerDOCUSATE SODIUM, SENNOSIDESCVS Pharmacyb52181e3-fd84-479e-8590-18619f6c0dae2024-03-13WarningsExact identifier
unii: F05Q2T2JA0
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Stool SoftenerDOCUSATE SODIUMCVS Pharmacy5eb047d2-8317-4de3-9268-d206ca039e3d2024-03-13WarningsExact identifier
unii: F05Q2T2JA0
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: C151H8M554
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyf77c65b0-3e13-48ce-a2d9-36a9eba1851f2024-03-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy849b057a-dc46-423c-a2f4-b01f135a38032024-03-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy8d59fa14-fc7c-4146-ba59-c2a907356dd62024-03-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCostco Wholesalea19c20bd-84ff-4931-8312-2fbf0400e8e02024-03-06WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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