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 9 of 39 · 773 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
unii: F05Q2T2JA0
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
unii: F05Q2T2JA0
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: 1Q73Q2JULR
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
DOCUSATE SODIUM 100MGDOCUSATE SODIUM 100MGFarmacias De Similares TX LLC44269b79-a5ad-f443-e063-6294a90a84732026-01-28WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Laboratories Limited3cf42333-7479-940a-e063-6394a90aedee2026-01-23WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC1f6c3b64-0fcd-4cd3-9947-453d794682922026-01-19WarningsExact identifier
unii: F05Q2T2JA0
DOCUSATE SODIUMDOCUSATE SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
unii: F05Q2T2JA0
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Megestrol AcetateMEGESTROL ACETATEMajor Pharmaceuticalse44cf173-991b-43cf-93f2-e0efaa4cc29a2026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATENatco Pharma USA LLC582cff8a-1def-43d6-ba7e-dce49e3e9f272026-01-15Warnings, Adverse reactionsExact identifier
application number: ANDA075671
ndc (package): 69339-160-16
ndc (package): 69339-160-19
ndc (package): 69339-160-18
ndc (package): 69339-160-17
ndc (package): 69339-160-01
ndc (product): 69339-160
ndc11 (package): 69339016001
rxcui: 860225
spl id: 2de58bb1-eff3-471a-8760-7006d7c54030
spl set id: 582cff8a-1def-43d6-ba7e-dce49e3e9f27
unii: TJ2M0FR8ES
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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