FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
43063-467
11-digit product format
430630467
Labeler code
43063
Product ID
43063-467_4d52a1c6-bbc0-0b02-e063-6294a90afa45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA074514
Marketing category
ANDA
Marketing start
1996-03-26
Substance
DICLOFENAC SODIUM
Active strength
50 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
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 SODIUM50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855906

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
43063-467-14Diclofenac Sodium14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1426
43063-467-15Diclofenac Sodium15 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1526
43063-467-20Diclofenac Sodium20 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE2026
43063-467-30Diclofenac Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-467-14EA - Each43063-467d2a3c675-df2a-4d73-b2a2-e7c42750871c12016-01-13
43063-467-15EA - Each43063-46732f97cee-808b-4127-b060-009da0cd674e12014-08-01
43063-467-20EA - Each43063-4676be6a745-f41e-462a-97e9-a9defe85199012021-02-05
43063-467-30EA - Each43063-4674133ca14-71b3-4631-8f06-d4938d18ae5112021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC SODIUMACTIVE INGREDIENTQTG126297QDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
DICLOFENACACTIVE MOIETY144O8QL0L1DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-467DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 4 package rows20240420_663a3dbc-a631-4046-8852-ec619c41c81d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855906diclofenac sodium 50 MG Delayed Release Oral TabletPSN663a3dbc-a631-4046-8852-ec619c41c81d26
855906diclofenac sodium 50 MG Delayed Release Oral TabletSCD663a3dbc-a631-4046-8852-ec619c41c81d26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-467-104306304671010 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-10) 2013-08-230000-00-00NoNoCurrent
43063-467-144306304671414 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-14) 2013-08-230000-00-00NoNoCurrent
43063-467-154306304671515 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-15) 2013-08-230000-00-00NoNoCurrent
43063-467-204306304672020 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20) 2013-08-230000-00-00NoNoCurrent
43063-467-304306304673030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-30) 2013-08-230000-00-00NoNoCurrent