FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
0115-1483
11-digit product format
001151483
Labeler code
0115
Product ID
0115-1483_5104bb6d-35c6-4106-90dc-f70b98025d2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200936
Marketing category
ANDA
Marketing start
2013-11-21
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855642

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1483-56Diclofenac Sodium1 in 1 CARTONGEL121
0115-1483-56Diclofenac Sodium50 g in 1 TUBEGEL5021
0115-1483-61Diclofenac Sodium100 g in 1 TUBEGEL10021
0115-1483-61Diclofenac Sodium1 in 1 CARTONGEL121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1483-61GM - Gram0115-14831379a94b-50bd-4b42-95e8-d745910c44a112013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYDICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5DICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
PEG-7 METHYL ETHERINACTIVE INGREDIENTENK4Y6S66XDICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDICLOFENAC SODIUM GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1483DICLOFENAC SODIUM GEL [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]21Current NDC, Legacy NDC, 4 package rows20241222_8aadab37-9068-45a8-ac9a-8ad87d163b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 0.03 MG/MG Topical GelSCD8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 3 % Topical GelSY8aadab37-9068-45a8-ac9a-8ad87d163b6821
855642diclofenac sodium 3 % Topical GelPSNf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 3 % Topical GelSYf187ae44-71be-a682-e053-2995a90a64263
855642diclofenac sodium 3 % Topical GelPSN1e39f8d4-56a2-4d29-a971-495574e8d4a71
855642diclofenac sodium 0.03 MG/MG Topical GelSCD1e39f8d4-56a2-4d29-a971-495574e8d4a71
855642diclofenac sodium 3 % Topical GelSY1e39f8d4-56a2-4d29-a971-495574e8d4a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1483-56001151483561 TUBE in 1 CARTON (0115-1483-56) / 50 g in 1 TUBE1 tube2013-11-210000-00-00NoNoCurrent
0115-1483-61001151483611 TUBE in 1 CARTON (0115-1483-61) / 100 g in 1 TUBE1 tube2013-11-210000-00-00NoNoCurrent