FDA.reportPublic FDA data

NDC 80425-0273-01 - DICLOENAC SODIUM and MISOPROSTOL DR

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
80425-0273
Requested NDC
80425-0273-01
Package NDCs from labels
80425-0273-1, 80425-0273-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DICLOENAC SODIUM and MISOPROSTOL DR - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-02-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0273-1DICLOENAC SODIUM and MISOPROSTOLDR60 in 1 BOTTLETABLET602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0273DICLOENAC SODIUM AND MISOPROSTOL DR (DICLOENAC SODIUM AND MISOPROSTOL) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20240224_f4d8c198-63e1-3109-e053-2995a90acad9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0273-1EA - Each80425-02733eacc955-b88d-467e-9b61-60fb0611f42812023-04-07

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 19 · 368 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions4c5b722e-0d1a-48e9-87c8-9b370b8ced462025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMBryant Ranch Prepack4e97c685-628a-4b83-ba9e-2d3caf65542b2025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC3d71f76d-bb23-7251-e063-6394a90aa9d82025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMBest Choice (Valu Merchandisers Company)4ea809a9-387a-4193-a176-d8b22eaa55e62025-08-21WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsca0f9295-4933-48d6-9387-90345fd5dcaa2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
ARTHROTECDICLOFENAC SODIUM AND MISOPROSTOLPfizer Laboratories Div Pfizer Inc600fe842-45d9-4d68-9ef2-456dbbebaa112025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359105
rxcui: 857706
unii: QTG126297Q
unii: 0E43V0BB57
DICLOFENAC SODIUMDICLOFENAC SODIUM TOPICAL GEL, 1%BluePoint Laboratories274543d2-a9a6-1e37-e063-6394a90ae3f12025-08-11WarningsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMRising Pharma Holdings, Inc.3330ea92-fc9d-4541-b378-be399b0995d32025-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOLDICLOFENAC SODIUM/MISOPROSTOLMicro Labs Limitedc61df58d-d6bb-4d3e-9ef8-60caa7d4e7622025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204355
ndc (product): 42571-134
rxcui: 1359105
rxcui: 857706
spl id: 3afc5367-562f-b4a0-e063-6294a90a2560
spl set id: c61df58d-d6bb-4d3e-9ef8-60caa7d4e762
unii: QTG126297Q
unii: 0E43V0BB57
Diclofenac SodiumDICLOFENAC SODIUMPHOENIX RX LLC3a4f7301-aa1c-9064-e063-6294a90a6eb42025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUM TOPICALPHOENIX RX LLC3a63e26f-27d7-9a25-e063-6294a90a55fe2025-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
DICLOFENAC SODIUMDICLOFENACEncube Ethicals, Inc.e7304b3e-530a-4519-aed0-bed4512d89252025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
unii: QTG126297Q
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMGolden State Medical Supply, Inc.39e67a90-df3e-ad30-e063-6394a90a7a822025-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.f9a0c654-5f77-430f-b921-295eb776cbcd2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac SodiumDICLOFENAC SODIUMAdvagen Pharma Ltdac2b4060-a5da-4ddf-a734-2ff58a1f98c92025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Diclofenac sodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.aa1e1ed3-0444-4bf5-a0ee-5d21a7fca3912025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: QTG126297Q
Arthritis Pain RelieverDICLOFENAC SODIUMChain Drug Consortium, LLC8879a2ed-6c66-4489-8adc-9f160241cc7d2025-06-25WarningsExact identifier
unii: QTG126297Q
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Companyc30353da-acd6-474f-8a64-abd078bf4f852025-06-11WarningsExact identifier
unii: QTG126297Q
members mark arthritis pain relieverDICLOFENAC SODIUMSam's West Inc44533b5b-73ce-4853-9eda-506426cb9b822025-06-09WarningsExact identifier
unii: QTG126297Q

Reported adverse events (FAERS/openFDA)#

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