Diclofenac Sodium

Product NDC
70518-2811
Requested package NDC
70518-2811-0
11-digit product format
705182811
Labeler code
70518
Product ID
70518-2811_4e42d4e0-b229-84ef-e063-6294a90ab3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
REMEDYREPACK INC.
Application
ANDA203818
Marketing category
ANDA
Marketing start
2020-07-10
Substance
DICLOFENAC SODIUM
Active strength
16.05 mg/mL
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203818-001DICLOFENAC SODIUMDICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A203818-001AT

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203818-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203818-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203818-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203818-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203818-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203818-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203818-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203818-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203818-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203818-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203818-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203818-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203818-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203818-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203818-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203818-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203818-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203818-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203818-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203818-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203818-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A203818-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203818-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203818-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203818-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A203818-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203818-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203818-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203818-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203818-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203818-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203818-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203818-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203818-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203818-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203818-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203818-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203818-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203818-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203818-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM16.05 mg/mL

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
857700Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d349d286-b462-4f8f-aa39-6173653175d6Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2811-0Diclofenac Sodium1 in 1 CARTONSOLUTION110
70518-2811-0Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION15010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2811-0ML - Milliliter70518-28113a1f9c28-6866-4224-b1d7-fbc3ad43c5e112026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2811DICLOFENAC SODIUM SOLUTION [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250403_d349d286-b462-4f8f-aa39-6173653175d6.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals, Inc.4a3549e0-1e2d-42bf-b82c-1e62837ba2e42026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMREMEDYREPACK INC.d349d286-b462-4f8f-aa39-6173653175d62026-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
ndc (package): 70518-2811-0
ndc (product): 70518-2811
ndc11 (package): 70518281100
DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRxd5f215d4-9aa3-2ecf-e053-2995a90a2e892026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.fae53d24-acf1-4250-888d-b8d965ffc3d32026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc.5508f80d-5f11-4959-8e42-9055f0169cfc2025-02-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMDirect_Rxf80b0b95-f4da-2d6c-e053-6294a90acf922025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx of Tennessee, LLC0803345d-7811-bc21-e063-6394a90aa6612024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutions0379c918-1717-40ab-81cc-268116950fd52023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LP1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818
Diclofenac sodiumDICLOFENAC SODIUMProficient Rx LPb0f9e649-6651-406f-a9fe-157fe04d9d272020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203818
application number: ANDA203818

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNd349d286-b462-4f8f-aa39-6173653175d610
857700diclofenac sodium 15 MG/ML Topical SolutionSCDd349d286-b462-4f8f-aa39-6173653175d610
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYd349d286-b462-4f8f-aa39-6173653175d610
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYd349d286-b462-4f8f-aa39-6173653175d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2811-0705182811001 BOTTLE, DROPPER in 1 CARTON (70518-2811-0) / 150 mL in 1 BOTTLE, DROPPER2020-07-100000-00-00NoNoCurrent