FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
69842-974
11-digit product format
698420974
Labeler code
69842
Product ID
69842-974_8a43a5cb-b6cc-4b7f-9152-02f79c71be3f
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
CVS Pharmacy
Application
ANDA208077
Marketing category
ANDA
Marketing start
2021-05-03
Marketing end
2026-12-30
Substance
DICLOFENAC SODIUM
Active strength
10 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633

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
69842-974-06Diclofenac sodium2 in 1 CARTONGEL211
69842-974-06Diclofenac sodium100 g in 1 TUBEGEL10011
69842-974-17Diclofenac sodium1 in 1 CARTONGEL111
69842-974-17Diclofenac sodium50 g in 1 TUBEGEL5011
69842-974-35Diclofenac sodium100 g in 1 TUBEGEL10011
69842-974-35Diclofenac sodium1 in 1 CARTONGEL111
69842-974-53Diclofenac sodium1 in 1 CARTONGEL111
69842-974-53Diclofenac sodium150 g in 1 TUBEGEL15011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-974-17GM - Gram69842-974596b6693-ec87-4763-8595-ba40e0e5a31e12021-07-15
69842-974-35GM - Gram69842-974f694da4d-7696-4373-9354-3e362b09662112021-07-15
69842-974-53GM - Gram69842-9742186c305-711b-4e08-ad98-4f18c5bc13b212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-974DICLOFENAC SODIUM GEL [CVS PHARMACY]10Current NDC, Legacy NDC, 8 package rows20221223_591cc2ed-e667-4779-a426-8a2e6f873573.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN591cc2ed-e667-4779-a426-8a2e6f87357311
855633diclofenac sodium 0.01 MG/MG Topical GelSCD591cc2ed-e667-4779-a426-8a2e6f87357311
855633diclofenac sodium 1 % Topical GelSY591cc2ed-e667-4779-a426-8a2e6f87357311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-974-06698420974062 TUBE in 1 CARTON (69842-974-06) / 100 g in 1 TUBE2 tube2021-05-032026-12-30NoNoCurrent
69842-974-17698420974171 TUBE in 1 CARTON (69842-974-17) / 50 g in 1 TUBE1 tube2021-05-032026-12-30NoNoCurrent
69842-974-35698420974351 TUBE in 1 CARTON (69842-974-35) / 100 g in 1 TUBE1 tube2021-05-032026-12-30NoNoCurrent
69842-974-53698420974531 TUBE in 1 CARTON (69842-974-53) / 150 g in 1 TUBE1 tube2021-05-032026-12-30NoNoCurrent