Home NDC 60290-084-03 Diclofenac Sodium
Product NDC 60290-084
Requested package NDC 60290-084-03
11-digit product format 602900084
Labeler code 60290
Product ID 60290-084_499a6352-e243-abaf-e063-6394a90a8ae4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Umedica Laboratories USA Inc.
Application ANDA219945
Marketing category ANDA
Marketing start 2026-02-15
Substance DICLOFENAC SODIUM
Active strength 75 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219945-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 A219945-002 DICLOFENAC SODIUM DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 A219945-003 DICLOFENAC SODIUM DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-02-19 14:30 UTC 2026-02 A219945-001 DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219945-002 DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219945-003 DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219945-001 DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219945-002 DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219945-003 DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219945-001 DICLOFENAC SODIUM 25MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219945-002 DICLOFENAC SODIUM 50MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219945-003 DICLOFENAC SODIUM 75MG TABLET, DELAYED RELEASE / ORAL AB 2025-11-05 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855664 Internal RxNorm lookup 855906 Internal RxNorm lookup 855926 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 60290-084-01 Diclofenac Sodium 60 in 1 BOTTLE TABLET, DELAYED RELEASE 60 6 60290-084-02 Diclofenac Sodium 100 in 1 BOTTLE TABLET, DELAYED RELEASE 100 6 60290-084-03 Diclofenac Sodium 500 in 1 BOTTLE TABLET, DELAYED RELEASE 500 6 60290-084-04 Diclofenac Sodium 1000 in 1 BOTTLE TABLET, DELAYED RELEASE 1000 6
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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 60290-084-03 60290008403 500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-03) 2026-02-15 No No Current