Home NDC 42291-042 Diclofenac Potassium
Product NDC 42291-042
11-digit product format 422910042
Labeler code 42291
Product ID 42291-042_484c1058-0a5d-1582-e063-6394a90a2985
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac potassium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA215585
Marketing category ANDA
Marketing start 2024-09-11
Substance DICLOFENAC POTASSIUM
Active strength 50 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215585-001 DICLOFENAC POTASSIUM DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215585-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A215585-001 DICLOFENAC POTASSIUM 50MG TABLET / ORAL AB 2021-10-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A215585-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Potassium DICLOFENAC POTASSIUM REMEDYREPACK INC. c4976d69-ca06-4263-9240-6fd8b44a9b6d 2026-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM Bryant Ranch Prepack e29e7aea-0bcd-46e5-b011-fbaf5aa2244a 2026-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM AvKARE 21dc9953-4e6d-50f0-e063-6294a90ac4ef 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 ndc (product): 42291-042 Diclofenac Potassium DICLOFENAC POTASSIUM Ingenus Pharmaceuticals, LLC 6926444f-0dca-4aeb-812e-755a83b149f4 2025-10-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585 Diclofenac Potassium DICLOFENAC POTASSIUM Preferred Pharmaceuticals Inc. 4f482f98-ef10-45d7-8e9f-9cf291d93092 2025-03-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215585 application number: ANDA215585
Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Potassium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC POTASSIUM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L4D5UA6CB4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855942 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-042-01 Diclofenac Potassium 100 in 1 BOTTLE TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-042 DICLOFENAC POTASSIUM TABLET, FILM COATED [AVKARE] 1 Current NDC, 1 package rows 20240913_21dc9953-4e6d-50f0-e063-6294a90ac4ef.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-042-01 42291004201 100 TABLET, FILM COATED in 1 BOTTLE (42291-042-01) 2024-09-11 No No Current