Home NDC 76420-261-01 Diclofenac Sodium
Product NDC 76420-261
Requested package NDC 76420-261-01
11-digit product format 764200261
Labeler code 76420
Product ID 76420-261_e709b84d-fa7d-3f23-e053-2995a90aacd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form GEL
Route TOPICAL
Labeler Asclemed USA, Inc.
Application ANDA206493
Marketing category ANDA
Marketing start 2016-05-19
Substance DICLOFENAC SODIUM
Active strength 30 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 A206493-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206493-001 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.
Product history page 1 of 2 · 41 observed 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 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206493-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2015-12-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 30 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 855642 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 76420-261-01 Diclofenac Sodium 1 in 1 CARTON GEL 1 1 76420-261-01 Diclofenac Sodium 100 g in 1 TUBE GEL 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-261 DICLOFENAC SODIUM GEL [ASCLEMED USA, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220826_b162d65d-b105-4a68-90bb-316b9686267b.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Sodium DICLOFENAC SODIUM Actavis Pharma, Inc. 74169b2d-ac56-4757-86c4-cdcfcd5f4eb5 2025-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206493 application number: ANDA206493 Diclofenac Sodium DICLOFENAC SODIUM Proficient Rx LP b41335b6-859f-4568-84d2-0d0408415a4e 2023-02-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206493 application number: ANDA206493 Diclofenac Sodium DICLOFENAC SODIUM Asclemed USA, Inc. b162d65d-b105-4a68-90bb-316b9686267b 2022-08-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206493 application number: ANDA206493 ndc (package): 76420-261-01 ndc (product): 76420-261 ndc11 (package): 76420026101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76420-261-01 76420026101 1 TUBE in 1 CARTON (76420-261-01) / 100 g in 1 TUBE 1 tube 2022-08-24 0000-00-00 No No Current