Diclofenac Sodium

Product NDC
61442-103
11-digit product format
614420103
Labeler code
61442
Product ID
61442-103_350d8fde-4096-17eb-e063-6394a90a9984
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Carlsbad Technology, Inc.
Application
ANDA075185
Marketing category
ANDA
Marketing start
1998-11-13
Substance
DICLOFENAC SODIUM
Active strength
75 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
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075185-001DICLOFENAC SODIUMDICLOFENAC SODIUM75MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-002DICLOFENAC SODIUMDICLOFENAC SODIUM25MGTABLET, DELAYED RELEASE / ORALAB1998-11-13
A075185-003DICLOFENAC SODIUMDICLOFENAC SODIUM50MGTABLET, DELAYED RELEASE / ORALAB1998-11-13

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A075185-001AB
A075185-002AB
A075185-003AB

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac Sodium Delayed ReleaseDICLOFENAC SODIUMCarlsbad Technology, Inc.40879600-ba6c-43a8-aa5d-d0d41503d5932025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS ). Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS , WARNINGS ). Gastrointestinal Bleeding, Ulceration, And Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS ).

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Cardiovascular Thromboic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CVdisease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 -14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS ). Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS SECTION The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS ) GI Bleeding, Ulceration and Perforation (see WARNINGS ) Hepatotoxicity (see WARNINGS ) Hypertension (see WARNINGS ) Heart Failure and Edema (see WARNINGS ) Renal Toxicity and Hyperkalemia (see WARNINGS ) Anaphylactic Reactions (see WARNINGS ) Serious Skin Reactions (see WARNINGS ) Hematologic Toxicity (see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus. Additional adverse experiences reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System : congestive heart failure, hypertension, tachycardia, syncope Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System : ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional : weight changes Nervous System : anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia,malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System : asthma, dyspnea Skin and Appendages : alopecia, photosensitivity, sweating increased Special Senses : blurred vision Urogenital System : cystitis, dysuria, hematuria, interstitial nephritis, oliguria/ polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System : arrhythmia, hypotension, myo...

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906, 855926

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
61442-103-01Diclofenac SodiumDelayed Release100 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10013
61442-103-05Diclofenac SodiumDelayed Release500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50013
61442-103-10Diclofenac SodiumDelayed Release1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE100013
61442-103-60Diclofenac SodiumDelayed Release60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6013
61442-103-60Inflammacin60 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE6075 mg5
61442-103-60Flexipak60 in 1 BOTTLETABLET, DELAYED RELEASE6075 mg1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61442-103-01EA - Each61442-103a6f68ade-8f2f-4290-9a4d-24b06a18367e12012-07-24
61442-103-05EA - Each61442-103dc27c1a1-3250-4f28-bc1f-74600168442c12012-07-24
61442-103-10EA - Each61442-1033c213f37-bde3-4bce-8dc5-b2f745a6936412012-07-24
61442-103-60EA - Each61442-103875c53c2-6aae-45bd-a7ba-faaff7b69d1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
PovidonesINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
ShellacINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
talcINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMDICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]4
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
POLYETHYLENE GLYCOL 2000INACTIVE INGREDIENTHAF0412YITDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71ODICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61442-103DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]12Current NDC, Legacy NDC, 4 package rows20240809_40879600-ba6c-43a8-aa5d-d0d41503d593.zip
61442-103INFLAMMACIN (DICLOFENAC SODIUM, CAPSAICIN) KIT [PURETEK CORPORATION]5Current NDC, Legacy NDC20241206_91d25301-fac9-41f0-8a4e-e22d44926347.zip
61442-103FLEXIPAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [STERLING-KNIGHT PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC20180127_7c14a409-88c5-4b9d-80a4-f9f80c64ebbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d103
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN7bf19e84-4f75-4d5c-9927-99220c58b572103
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD7bf19e84-4f75-4d5c-9927-99220c58b572103
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDdf5bb0e7-a3a9-4650-aae7-9a11ce615d5d103
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNe6a1ff58-a541-46f8-9663-eed53b7cf392102
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN7c3d8d33-8849-44df-bb57-57d32b96a0e4102
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNbced0ef0-085a-40db-9678-2bc6eb77d456102
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD7c3d8d33-8849-44df-bb57-57d32b96a0e4102
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDbced0ef0-085a-40db-9678-2bc6eb77d456102
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDe6a1ff58-a541-46f8-9663-eed53b7cf392102
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN70156824-e5dd-42b1-9b4f-a49acb28d31643
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN70156824-e5dd-42b1-9b4f-a49acb28d31643
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD70156824-e5dd-42b1-9b4f-a49acb28d31643
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD70156824-e5dd-42b1-9b4f-a49acb28d31643
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN58063c26-86fe-4f03-97ef-51706e5f405420
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD58063c26-86fe-4f03-97ef-51706e5f405420
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN10991fe6-fafd-49af-9684-83b447c19c6717
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD19b4ff5c-adb7-a0d0-7ef2-4ae05047fd9417
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD10991fe6-fafd-49af-9684-83b447c19c6717
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN40879600-ba6c-43a8-aa5d-d0d41503d59313
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN40879600-ba6c-43a8-aa5d-d0d41503d59313
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN30c7e4fd-30af-4d28-a6ef-7386ff83cfb813
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD40879600-ba6c-43a8-aa5d-d0d41503d59313
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD40879600-ba6c-43a8-aa5d-d0d41503d59313
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD30c7e4fd-30af-4d28-a6ef-7386ff83cfb813
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD2ae3c1e2-f053-4efb-9597-eeac4998d23f12
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNc933eaad-ba53-4130-90db-a66f89dfc29f9
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDc933eaad-ba53-4130-90db-a66f89dfc29f9
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN5b4c1a15-ed93-7192-e053-2991aa0a83608
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN4ecb7bdc-4a5e-7444-e054-00144ff88e888
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD5b4c1a15-ed93-7192-e053-2991aa0a83608
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD4ecb7bdc-4a5e-7444-e054-00144ff88e888
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN89ccfc76-245f-4604-bc1d-9115c657c3407
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNaf8a1392-67e8-8201-e053-2a95a90a0fce7
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN89ccfc76-245f-4604-bc1d-9115c657c3407
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD89ccfc76-245f-4604-bc1d-9115c657c3407
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDaf8a1392-67e8-8201-e053-2a95a90a0fce7
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD89ccfc76-245f-4604-bc1d-9115c657c3407
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN73a46413-ecbc-4453-814d-bec955b375d26
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNd424ab84-2aaa-38a9-e053-2a95a90adde96
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD73a46413-ecbc-4453-814d-bec955b375d26
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDd424ab84-2aaa-38a9-e053-2a95a90adde96
198555capsaicin 0.025 % Topical CreamPSN91d25301-fac9-41f0-8a4e-e22d449263475
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN91d25301-fac9-41f0-8a4e-e22d449263475
198555capsaicin 0.25 MG/ML Topical CreamSCD91d25301-fac9-41f0-8a4e-e22d449263475
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD91d25301-fac9-41f0-8a4e-e22d449263475
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDb2d71822-a7f3-447c-911c-971a21af53465
198555capsaicin 0.025 % Topical CreamSY91d25301-fac9-41f0-8a4e-e22d449263475
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN770b5db0-3565-409d-a274-caa132fb8d894
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNc16e7e43-3869-9fef-e053-2995a90a1fdb4
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD770b5db0-3565-409d-a274-caa132fb8d894
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDc16e7e43-3869-9fef-e053-2995a90a1fdb4
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDafce2de2-0c59-4191-bf79-782ca31e427d4
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN8bda6135-c957-6b4e-e053-2995a90a0cb53
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCD8bda6135-c957-6b4e-e053-2995a90a0cb53
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNf7ec92b6-1601-4f4e-87c8-531aae302f532
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNfd544812-d7a9-47c8-9148-bea26c8b66c72
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDf7ec92b6-1601-4f4e-87c8-531aae302f532
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDfd544812-d7a9-47c8-9148-bea26c8b66c72
198555capsaicin 0.025 % Topical CreamPSN7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN903b8d44-bfd7-718f-e053-2a95a90a712c1
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN903b77bf-6de1-2705-e053-2a95a90a0b931
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN39e67a90-df3e-ad30-e063-6394a90a7a821
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSN41472cca-278b-934b-e063-6294a90aaf5d1
198555capsaicin 0.25 MG/ML Topical CreamSCD7c14a409-88c5-4b9d-80a4-f9f80c64ebbf1
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD39e67a90-df3e-ad30-e063-6394a90a7a821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61442-103-0161442010301100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-01) 1998-11-130000-00-00NoNoCurrent
61442-103-0561442010305500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-05) 1998-11-130000-00-00NoNoCurrent
61442-103-10614420103101000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-10) 1998-11-130000-00-00NoNoCurrent
61442-103-606144201036060 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) 1998-11-130000-00-00NoNoCurrent