Home NDC 21922-033 DICLOFENAC SODIUM
Product NDC 21922-033
11-digit product format 219220033
Labeler code 21922
Product ID 21922-033_28dafbef-5a91-4435-b48d-00137ea268b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DICLOFENAC
Dosage form SOLUTION
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA217646
Marketing category ANDA
Marketing start 2025-04-14
Substance DICLOFENAC SODIUM
Active strength 20 mg/g
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 2026-12-31
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 A217646-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2025-04-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217646-001 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 2026-02-19 14:30 UTC 2026-02 A217646-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2025-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217646-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2025-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217646-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2025-04-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217646-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2025-04-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217646-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217646-001 AB 1 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217646-001 AB 1 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217646-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base DICLOFENAC SODIUM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 20 mg/g
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1487074 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 21922-033-16 DICLOFENAC SODIUM 1 in 1 CARTON SOLUTION 1 4 21922-033-16 DICLOFENAC SODIUM 112 g in 1 BOTTLE, PUMP SOLUTION 112 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-033 DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] 3 Current NDC, 2 package rows 20250419_e7304b3e-530a-4519-aed0-bed4512d8925.zip
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 21922-033-16 21922003316 1 BOTTLE, PUMP in 1 CARTON (21922-033-16) / 112 g in 1 BOTTLE, PUMP 2025-04-14 No No Current