FDA.reportPublic FDA data

DICLOFENAC SODIUM

Substance profile for UNII QTG126297Q, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for DICLOFENAC SODIUM
Structure render from PubChem CID 5018304

Substance Identity#

UNII
QTG126297Q
Preferred term
DICLOFENAC SODIUM
Registry number
15307-79-6
EC number
239-346-4
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C14H10Cl2NO2.Na
Chemical structure for DICLOFENAC SODIUM
Structure render from PubChem CID 5018304

Chemical And Database Identifiers#

InChIKey
KPHWPUGNDIVLNH-UHFFFAOYSA-M
SMILES
[Na+].[O-]C(=O)CC1=CC=CC=C1NC2=C(Cl)C=CC=C2Cl
RxCUI
203214
PubChem
5018304
NCIt
C47984
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5018304pubchem.ncbi.nlm.nih.gov/compound/5018304
PubChem InChIKey SearchKPHWPUGNDIVLNH-UHFFFAOYSA-Mpubchem.ncbi.nlm.nih.gov/#query=KPHWPUGNDIVLNH-UHFFFAOYSA-M
RxNorm203214mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=203214
NCI ThesaurusC47984ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47984
FDA Substance Registration SystemQTG126297Qprecision.fda.gov/uniisearch/srs/unii/QTG126297Q
European Community number239-346-4commonchemistry.cas.org/results?q=239-346-4

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
Inflamation Reduction Pack These highlights do not include all the information needed to use Inflammation Reduction Pack safely and effectively.see full prescribing information for Inflammation Reduction Pack Inflammation Reduction Pack (Inflammation Reduction Pack) KIT for use. Initial U.S. Approval:4
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 40-9184 Revised – August 2015 Rx Only Prescribing Information2
Inflamation Reduction Pack These highlights do not include all the information needed to use Inflammation Reduction Pack safely and effectively.see full prescribing information for Inflammation Reduction Pack Inflammation Reduction Pack (Inflammation Reduction Pack) KIT for use. Initial U.S. Approval:3
Diclofenac Sodium Extended-release Tablets8
Diclofenac Sodium and Misoprostol Delayed-Release Tablets1
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg2
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
Inflamation Reduction Pack2
VOLTAREN2
1cac4fd0-70cb-2bbf-e054-00144ff8d46c2
1c948de4-dbbf-309a-e054-00144ff8d46c1
1b49b08b-8494-3f71-e054-00144ff88e881
DICLOFENAC SODIUM1
Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 20121
DICLOFENAC SODIUM1
Diclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg6
Diclofenac sodium and misoprostol delayed-release tablets3
Diclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
Diclofenac Sodium Delayed-Release Tablets USP1
Diclofenac Sodium Delayed-release Tablets, USP 40-9184 Revised – June 20122
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
Diclofenac Sodium Delayed-Release Tablets USP4
Diclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing Information2
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP3
Diclofenac Sodium Delayed-release Tablets, USP2
VOLTAREN OPHTHAMIC ® (diclofenac sodium ophthalmic solution) 0.1% Sterile Ophthalmic Solution Rx only Prescribing Information7
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP2
Diclofenac Sodium Delayed-release Tablets, USP 40-8780 Revised – March 20111
Diclofenac Sodium Delayed-release Tablets, USP 50 mg1
ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets1
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg3
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19885
DICLOFENAC SOD DR4
Diclofenac Sodium Delayed-Release Tablets USP1
ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets5
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
Diclofenac Sodium Delayed-release Tablets USP, 25 mg, 50 mg and 75 mg1
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)1
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP1
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)2
bd27460e-46ff-4450-a4f2-a41420c1f93d2
42fcf2b5-3466-4493-8a47-c4675538ece31
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
These highlights do not include all the information needed to use PENNSAID ® safely and effectively. See full prescribing information for PENNSAID. PENNSAID (diclofenac sodium topical solution) 1.5% w/w is for topical use only. Initial U.S. Approval: 19881
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)1
Diclofenac Sodium Delayed-release Tablets, USP 75 mg1
These highlights do not include all the information needed to use Voltaren® Gel safely and effectively. See full prescribing information for Voltaren® Gel. Initial U.S. Approval: 19881
ARTHROTEC ® (diclofenac sodium/misoprostol) Tablets1
diclofenac sodium (Diclofenac Sodium) tablet2
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP1
Diclofenac Sodium Delayed-Release Tablets USP 25 mg, 50 mg, 75 mg1
Diclofenac Sodium Ophthalmic Solution, 0.1%1
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3965
DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3744
ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3585
VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3191
DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1001
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
VOLTAREN (DICLOFENAC SODIUM) GEL [BRYANT RANCH PREPACK]1000
DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]22
ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC]21
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [SANDOZ INC]15
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]12
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]12
PENNSAID (DICLOFENAC SODIUM) SOLUTION [MALLINCKRODT, INC]12
ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]10
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AVKARE, INC.]10
PENNSAID (DICLOFENAC SODIUM) LIQUID [MALLINCKRODT, INC]10
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC.]8
DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED [GREENSTONE LLC]7
DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.]7
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]7
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
DICLOFENAC SODIUM TABLET, DELAYED RELEASE DICLOFENAC SODIUM TABLET, DELAYED RELEASE [RISING PHARMACEUTICALS, INC.]7
DICLOFENAC SODIUM SOLUTION [ACTAVIS PHARMA, INC.]6
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]6
SOLARAZE (DICLOFENAC SODIUM) GEL [PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.]6
VOLTAREN (DICLOFENAC SODIUM) GEL [ENDO PHARMACEUTICALS INC.]6
DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]5
DICLOFENAC SODIUM EXTENDED-RELEASE (DICLOFENAC SODIUM) TABLET, EXTENDED RELEASE [ST MARYS MEDICAL PARK PHARMACY]5
DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS ELIZABETH LLC]5
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]5
ARTHROTEC (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, FILM COATED [BRYANT RANCH PREPACK]4
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]4
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]4
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ST MARYS MEDICAL PARK PHARMACY]4
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
DERMACINRX INFLAMMATRAL PAK (DICLOFENAC SODIUM DELAYED RELEASE TABLETS, RANITIDINE TABLETS, CAPSAICIN CREAM) KIT [PURETEK CORPORATION]3
DICLOFENAC (DICLOFENAC SODIUM) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.]3
DICLOFENAC SODIUM (DICLOFENAC SODIUM) SOLUTION [TELIGENT PHARMA, INC.]3
DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE [BLUEPOINT LABORATORIES]3
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]3
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]3
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]3
PENNSAID (DICLOFENAC SODIUM) LIQUID [UNIT DOSE SERVICES]3
DICLOFENAC (DICLOFENAC SODIUM) SOLUTION/ DROPS [AKORN, INC.]2
DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL) TABLET, DELAYED RELEASE [AVKARE, INC.]2
DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
DICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]2
DICLOFENAC SODIUM SOLUTION [PADDOCK LABORATORIES, LLC]2
DICLOFENAC SODIUM SOLUTION [SANDOZ INC]2
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE]2
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]2
DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC. ]2
DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2
DICLOFENAC SODIUM TABLET, EXTENDED RELEASE [REMEDYREPACK INC. ]2
DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS, INC.]2
GAPEAM BUDIBAC (AMANTADINE HCL, BACLOFEN, BUPIVACAINE HCL, CYCLOBENZAPRINE HCL, DICLOFENAC SODIUM, GABAPENTIN, AND PENTOXIFYLLINE) KIT [ALVIX LABORATORIES, LLC]2
SURPASS (DICLOFENAC SODIUM) CREAM [BOEHRINGER INGELHEIM VETMEDICA, INC.]2