Home NDC 50090-4016-0 Diclofenac Sodium
Product NDC 50090-4016
Requested package NDC 50090-4016-0
11-digit product format 500904016
Labeler code 50090
Product ID 50090-4016_fc0e2c12-0fb8-4da0-9f9f-c42ff8581294
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION
Route TOPICAL
Labeler A-S Medication Solutions
Application ANDA202027
Marketing category ANDA
Marketing start 2014-05-28
Marketing end 0000-00-00
Substance DICLOFENAC SODIUM
Active strength 16 mg/mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A202027-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27
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 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL AT RS 2014-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202027-001 DICLOFENAC SODIUM 1.5% SOLUTION / TOPICAL 2014-05-27 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4016-0 Diclofenac Sodium 1 in 1 CARTON SOLUTION 1 1 50090-4016-0 Diclofenac Sodium 150 mL in 1 BOTTLE SOLUTION 150 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4016 DICLOFENAC SODIUM SOLUTION [A-S MEDICATION SOLUTIONS] 1 Legacy NDC, 2 package rows 20190123_2bf4c5e6-8486-473f-9692-34394079ec2c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Varophen DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE V2 Pharma, LLC 1bef5035-70ad-4f75-80c3-6252cd01fa85 2024-12-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 202027 application number: ANDA202027
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 50090-4016-0 50090401600 1 BOTTLE in 1 CARTON (50090-4016-0) > 150 mL in 1 BOTTLE 1 bottle 2019-01-03 0000-00-00 No No Current