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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1483-56ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0115-1483-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1483-56367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0115-1483-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1483-56557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0115-1483-61557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200936-001DICLOFENAC SODIUMDICLOFENAC SODIUM3%GEL / TOPICAL2013-10-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A200936-001DICLOFENAC SODIUM3%GEL / TOPICAL2013-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-283f01610625f2…
2019-09-15 20:21 UTC2019-09A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200936-001DICLOFENAC SODIUM3%GEL / TOPICALAB2013-10-28e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200936-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200936-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200936-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200936-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200936-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200936-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200936-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200936-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200936-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200936-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200936-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200936-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200936-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200936-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200936-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200936-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200936-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200936-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200936-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200936-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200936-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200936-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200936-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200936-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200936-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200936-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200936-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200936-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200936-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200936-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200936-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200936-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200936-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200936-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200936-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200936-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200936-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200936-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200936-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200936-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855642Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8aadab37-9068-45a8-ac9a-8ad87d163b68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1483-56Diclofenac Sodium1 in 1 CARTONGEL121
0115-1483-56Diclofenac Sodium50 g in 1 TUBEGEL5021
0115-1483-61Diclofenac Sodium100 g in 1 TUBEGEL10021
0115-1483-61Diclofenac Sodium1 in 1 CARTONGEL121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1483-61GM - Gram0115-14831379a94b-50bd-4b42-95e8-d745910c44a112013-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1483DICLOFENAC SODIUM GEL [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]21Current NDC, Legacy NDC, 4 package rows20241222_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf187ae44-71be-a682-e053-2995a90a64262024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200936
application number: ANDA200936
Diclofenac SodiumDICLOFENAC SODIUMAmneal Pharmaceuticals of New York LLC8aadab37-9068-45a8-ac9a-8ad87d163b682024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200936
application number: ANDA200936
ndc (product): 0115-1483
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.1e39f8d4-56a2-4d29-a971-495574e8d4a72020-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200936
application number: ANDA200936

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 0.03 MG/MG Topical GelSCD8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 3 % Topical GelSY8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 3 % Topical GelPSNf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 3 % Topical GelSYf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 3 % Topical GelPSN1e39f8d4-56a2-4d29-a971-495574e8d4a71
855642diclofenac sodium 0.03 MG/MG Topical GelSCD1e39f8d4-56a2-4d29-a971-495574e8d4a71
855642diclofenac sodium 3 % Topical GelSY1e39f8d4-56a2-4d29-a971-495574e8d4a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1483-56001151483561 TUBE in 1 CARTON (0115-1483-56) / 50 g in 1 TUBE1 tube2013-11-210000-00-00NoNoCurrent
0115-1483-61001151483611 TUBE in 1 CARTON (0115-1483-61) / 100 g in 1 TUBE1 tube2013-11-210000-00-00NoNoCurrent