FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
51672-1358
11-digit product format
516721358
Labeler code
51672
Product ID
51672-1358_4b20d36c-e921-489d-e063-6294a90ad63b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA203818
Marketing category
ANDA
Marketing start
2014-11-26
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

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 Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui857700

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1358-2Diclofenac Sodium1 in 1 CARTONSOLUTION113
51672-1358-2Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION15013
51672-1358-4Diclofenac Sodium60 mL in 1 BOTTLE, DROPPERSOLUTION6013
51672-1358-4Diclofenac Sodium1 in 1 CARTONSOLUTION113
51672-1358-2Clofenax150 mL in 1 BOTTLE, DROPPERSOLUTION150 mL16.05 mg in 1mL3
51672-1358-2Clofenax1 in 1 CARTONSOLUTION16.05 mg in 1mL3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1358-2ML - Milliliter51672-13583cbc277c-c918-43ae-bce6-4cff117c87f912015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diclofenac SodiumACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
DiclofenacACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
alcoholINACTIVE INGREDIENT3K9958V90MDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
dimethyl sulfoxideINACTIVE INGREDIENTYOW8V9698HDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
glycerinINACTIVE INGREDIENTPDC6A3C0OXDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5
waterINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1358DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 package rows20220814_fae53d24-acf1-4250-888d-b8d965ffc3d3.zip
51672-1358CLOFENAX (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]2Current NDC, Legacy NDC20230112_b60e6572-0624-40c5-e053-2995a90ade48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNfae53d24-acf1-4250-888d-b8d965ffc3d313
857700diclofenac sodium 15 MG/ML Topical SolutionSCDfae53d24-acf1-4250-888d-b8d965ffc3d313
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYfae53d24-acf1-4250-888d-b8d965ffc3d313
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYfae53d24-acf1-4250-888d-b8d965ffc3d313
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
857700diclofenac sodium 1.5 % Topical SolutionPSN4a3549e0-1e2d-42bf-b82c-1e62837ba2e47
857700diclofenac sodium 15 MG/ML Topical SolutionSCD4a3549e0-1e2d-42bf-b82c-1e62837ba2e47
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY4a3549e0-1e2d-42bf-b82c-1e62837ba2e47
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY4a3549e0-1e2d-42bf-b82c-1e62837ba2e47
857700diclofenac sodium 1.5 % Topical SolutionPSNf267b75c-e141-41dd-e053-2995a90afe304
857700diclofenac sodium 15 MG/ML Topical SolutionSCDf267b75c-e141-41dd-e053-2995a90afe304
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYf267b75c-e141-41dd-e053-2995a90afe304
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYf267b75c-e141-41dd-e053-2995a90afe304
1039731camphor 4 % / menthol 10 % Topical GelPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
198555capsaicin 0.025 % Topical CreamPSN042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % Topical SolutionPSN1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 1.5 % Topical SolutionPSN1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % Topical SolutionPSNd5f215d4-9aa3-2ecf-e053-2995a90a2e893
857700diclofenac sodium 1.5 % Topical SolutionPSNb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 1.5 % Topical SolutionPSN042765e5-bd75-8224-e063-6394a90a141b3
1039731camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical GelSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
198555capsaicin 0.25 MG/ML Topical CreamSCD042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 15 MG/ML Topical SolutionSCDd5f215d4-9aa3-2ecf-e053-2995a90a2e893
857700diclofenac sodium 15 MG/ML Topical SolutionSCDb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 15 MG/ML Topical SolutionSCD042765e5-bd75-8224-e063-6394a90a141b3
1039731camphor 4 % / menthol 10 % Topical GelSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
198555capsaicin 0.025 % Topical CreamSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYd5f215d4-9aa3-2ecf-e053-2995a90a2e893
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1e2bb4e5-bb65-48a0-e063-6294a90a54d13
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYd5f215d4-9aa3-2ecf-e053-2995a90a2e893
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1e2a687b-a838-9b16-e063-6394a90a69f33
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYb60e6572-0624-40c5-e053-2995a90ade483
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY042765e5-bd75-8224-e063-6394a90a141b3
857700diclofenac sodium 1.5 % Topical SolutionPSN1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1c1ee94c-60d6-4cfc-bb66-1d4f6e6305122
857700diclofenac sodium 1.5 % Topical SolutionPSN0379c918-1717-40ab-81cc-268116950fd51
857700diclofenac sodium 1.5 % Topical SolutionPSNbc185822-4754-ff6c-e053-2995a90a7c0e1
857700diclofenac sodium 1.5 % Topical SolutionPSNb42e8082-557b-ab2b-e053-2995a90a622c1
857700diclofenac sodium 1.5 % Topical SolutionPSN5508f80d-5f11-4959-8e42-9055f0169cfc1
857700diclofenac sodium 15 MG/ML Topical SolutionSCDbc185822-4754-ff6c-e053-2995a90a7c0e1
857700diclofenac sodium 15 MG/ML Topical SolutionSCDb42e8082-557b-ab2b-e053-2995a90a622c1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD5508f80d-5f11-4959-8e42-9055f0169cfc1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD0379c918-1717-40ab-81cc-268116950fd51
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYbc185822-4754-ff6c-e053-2995a90a7c0e1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYb42e8082-557b-ab2b-e053-2995a90a622c1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY5508f80d-5f11-4959-8e42-9055f0169cfc1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY0379c918-1717-40ab-81cc-268116950fd51
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYbc185822-4754-ff6c-e053-2995a90a7c0e1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYb42e8082-557b-ab2b-e053-2995a90a622c1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY5508f80d-5f11-4959-8e42-9055f0169cfc1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY0379c918-1717-40ab-81cc-268116950fd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1358-2516721358021 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER2014-11-260000-00-00NoNoCurrent
51672-1358-4516721358041 BOTTLE, DROPPER in 1 CARTON (51672-1358-4) > 60 mL in 1 BOTTLE, DROPPER2014-11-260000-00-00NoNoCurrent