Home NDC 0115-1483 Diclofenac Sodium
Product NDC 0115-1483
11-digit product format 001151483
Labeler code 0115
Product ID 0115-1483_5104bb6d-35c6-4106-90dc-f70b98025d2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form GEL
Route TOPICAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA200936
Marketing category ANDA
Marketing start 2013-11-21
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0115-1483-56 ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0115-1483-61 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-1483-56 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0115-1483-61 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-1483-56 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0115-1483-61 557ba5c1ecfa…9c80585c8c6e…
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 A200936-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 3% GEL / TOPICAL 2013-10-28
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 · 42 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 2026-08-18 06:07:40 2026-07 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL 2013-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200936-001 DICLOFENAC SODIUM 3% GEL / TOPICAL AB 2013-10-28 e64feba35796…
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 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 0115-1483-56 Diclofenac Sodium 1 in 1 CARTON GEL 1 21 0115-1483-56 Diclofenac Sodium 50 g in 1 TUBE GEL 50 21 0115-1483-61 Diclofenac Sodium 100 g in 1 TUBE GEL 100 21 0115-1483-61 Diclofenac Sodium 1 in 1 CARTON GEL 1 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1483 DICLOFENAC SODIUM GEL [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 21 Current NDC, Legacy NDC, 4 package rows 20241222_8aadab37-9068-45a8-ac9a-8ad87d163b68.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.
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 0115-1483-56 00115148356 1 TUBE in 1 CARTON (0115-1483-56) / 50 g in 1 TUBE 1 tube 2013-11-21 0000-00-00 No No Current 0115-1483-61 00115148361 1 TUBE in 1 CARTON (0115-1483-61) / 100 g in 1 TUBE 1 tube 2013-11-21 0000-00-00 No No Current