FDA.reportPublic FDA data

Diclofenac Potassium

Product NDC
51655-230
Requested package NDC
51655-230-52
11-digit product format
516550230
Labeler code
51655
Product ID
51655-230_48d2c42f-dd1c-d0e8-e063-6294a90a76f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA075229
Marketing category
ANDA
Marketing start
2022-10-27
Substance
DICLOFENAC POTASSIUM
Active strength
50 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075229-001DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-20
A075229-002DICLOFENAC POTASSIUMDICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075229-001AB
A075229-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075229-001DICLOFENAC POTASSIUM50MGTABLET / ORALABRS1998-11-20a50c72e98297…
2026-08-01 22:54:322026-06A075229-002DICLOFENAC POTASSIUM25MGTABLET / ORALAB2021-09-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075229-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075229-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac PotassiumDICLOFENAC POTASSIUMNuCare Pharmaceuticals,Inc.d61cbb27-737d-948c-e053-2a95a90adaca2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMBryant Ranch Prepack86461915-9bc1-43d4-8d92-6eef3e56bd902026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMNorthwind Health Company, LLCf2b6a4dd-e4e2-4acc-e053-2995a90aebf22026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
ndc (package): 51655-230-52
ndc (product): 51655-230
ndc11 (package): 51655023052
Diclofenac PotassiumDICLOFENAC POTASSIUMAdvagen Pharma Ltd82218d5c-1625-471a-aabe-f43338e5176b2025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMTrifluent Pharma LLC8fdb1036-c0d8-4288-ac37-6512b05672ef2025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMINA Pharmaceutics Inc5ecd99fe-cb74-4a65-9636-2aefd2416ece2025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMCoupler LLC2eead069-f954-abb2-e063-6394a90a14ff2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMA-S Medication Solutions112e7c94-23c8-451e-ae71-eb89a6eb2cb22023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229
Diclofenac PotassiumDICLOFENAC POTASSIUMProficient Rx LP94586867-c75b-4d60-be1d-03a9e4b7cd102023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075229
application number: ANDA075229

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L4D5UA6CB4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855942Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2b6a4dd-e4e2-4acc-e053-2995a90aebf2Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-230-52Diclofenac Potassium30 in 1 BOTTLE, PLASTICTABLET, COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-230DICLOFENAC POTASSIUM TABLET, COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230324_f2b6a4dd-e4e2-4acc-e053-2995a90aebf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855942diclofenac potassium 50 MG Oral TabletPSNf2b6a4dd-e4e2-4acc-e053-2995a90aebf22
855942diclofenac potassium 50 MG Oral TabletSCDf2b6a4dd-e4e2-4acc-e053-2995a90aebf22
855942Diclofenac K+ 50 MG Oral TabletSYf2b6a4dd-e4e2-4acc-e053-2995a90aebf22
855942Diclofenac Pot 50 MG Oral TabletSYf2b6a4dd-e4e2-4acc-e053-2995a90aebf22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-230-525165502305230 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-230-52) 2022-10-27NoNoCurrent