Home NDC 42291-055 Diclofenac sodium
Product NDC 42291-055
11-digit product format 422910055
Labeler code 42291
Product ID 42291-055_484c1f52-6419-1ce3-e063-6394a90aa297
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac sodium
Dosage form SOLUTION
Route TOPICAL
Labeler AvKARE
Application ANDA212506
Marketing category ANDA
Marketing start 2023-08-29
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 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 A212506-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212506-001 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 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212506-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-11-29 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 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 42291-055-12 Diclofenac sodium 112 g in 1 BOTTLE, PUMP SOLUTION 112 2 42291-055-12 Diclofenac sodium 1 in 1 BOX SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-055 DICLOFENAC SODIUM SOLUTION [AVKARE] 1 Current NDC, 2 package rows 20230830_0416ce03-c345-9d9e-e063-6294a90ad940.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac sodium DICLOFENAC SODIUM AvKARE 0416ce03-c345-9d9e-e063-6294a90ad940 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212506 application number: ANDA212506 ndc (product): 42291-055 Diclofenac sodium DICLOFENAC SODIUM Alembic Pharmaceuticals Limited 048ede6a-b7cd-4100-8979-519bd44906c8 2025-03-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212506 application number: ANDA212506 Diclofenac sodium DICLOFENAC SODIUM Alembic Pharmaceuticals Inc. 02e90e33-384f-4e29-b508-2503def22214 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212506 application number: ANDA212506 Diclofenac sodium DICLOFENAC SODIUM Advanced Rx Pharmacy of Tennessee, LLC fc0e1950-d76f-75bc-e053-6294a90a8c12 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212506 application number: ANDA212506 Diclofenac sodium DICLOFENAC SODIUM Quality Care Products, LLC 3ee4c4e1-f23b-4d4a-bac7-59546d3a2c8b 2024-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212506 application number: ANDA212506
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42291-055-12 42291005512 1 BOTTLE, PUMP in 1 BOX (42291-055-12) / 112 g in 1 BOTTLE, PUMP 2023-08-29 No No Current