Home NDC 65162-683 Diclofenac Sodium
Product NDC 65162-683
11-digit product format 651620683
Labeler code 65162
Product ID 65162-683_1affc043-5b84-4b94-97be-90f3bd954f34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac
Dosage form SOLUTION
Route TOPICAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA208198
Marketing category ANDA
Marketing start 2022-08-23
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 42 .
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 A208198-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208198-001 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 2026-08-18 06:07:40 2026-07 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208198-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-08-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 65162-683-12 Diclofenac Sodium 112 g in 1 BOTTLE SOLUTION 112 12 65162-683-12 Diclofenac Sodium 1 in 1 CARTON SOLUTION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-683 DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [AMNEAL PHARMACEUTICALS LLC] 11 Current NDC, Legacy NDC, 2 package rows 20241222_45321aec-368d-4ca4-a0c5-2ce56fae74b2.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 · 2 matching rows.
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 65162-683-12 65162068312 1 BOTTLE in 1 CARTON (65162-683-12) / 112 g in 1 BOTTLE 1 bottle 2022-08-23 0000-00-00 No No Current