FDA.reportPublic FDA data

ZIPSOR

Product NDC
13913-008
11-digit product format
139130008
Labeler code
13913
Product ID
13913-008_73f6a60d-3089-4936-84df-8c28c49cb441
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac potassium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Assertio Therapeutics, Inc.
Application
NDA022202
Marketing category
NDA
Marketing start
2009-06-16
Substance
DICLOFENAC POTASSIUM
Active strength
25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC POTASSIUM25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL4D5UA6CB4
Rxcui858342, 858346

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
13913-008-11ZIPSOR100 in 1 BOTTLECAPSULE, LIQUID FILLED10015
13913-008-12ZIPSOR120 in 1 BOTTLECAPSULE, LIQUID FILLED12015
13913-008-94ZIPSOR1 in 1 CARTONCAPSULE, LIQUID FILLED115
13913-008-94ZIPSOR4 in 1 BLISTER PACKCAPSULE, LIQUID FILLED415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13913-008-11EA - Each13913-008fda93636-a415-4c53-a647-71d9bd69903512013-05-02
13913-008-12EA - Each13913-008b8ec7123-b3f3-4d97-96ae-cde6b349b34a12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOFENAC POTASSIUMACTIVE INGREDIENTL4D5UA6CB4ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
DICLOFENACACTIVE MOIETY144O8QL0L1ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
GELATININACTIVE INGREDIENT2G86QN327LZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7
SORBITOLINACTIVE INGREDIENT506T60A25RZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [DEPOMED, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13913-008ZIPSOR (DICLOFENAC POTASSIUM) CAPSULE, LIQUID FILLED [ASSERTIO THERAPEUTICS, INC.]14Current NDC, Legacy NDC, 4 package rows20241215_c982eca0-fc41-11e1-a9c8-0002a5d5c51b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858342diclofenac potassium 25 MG Oral CapsulePSNc982eca0-fc41-11e1-a9c8-0002a5d5c51b15
858346Zipsor 25 MG Oral CapsulePSNc982eca0-fc41-11e1-a9c8-0002a5d5c51b15
858346diclofenac 25 MG Oral Capsule [Zipsor]SBDc982eca0-fc41-11e1-a9c8-0002a5d5c51b15
858342diclofenac 25 MG Oral CapsuleSCDc982eca0-fc41-11e1-a9c8-0002a5d5c51b15
858342diclofenac 25 MG (equivalent to diclofenac potassium 28.3 MG) Oral CapsuleSYc982eca0-fc41-11e1-a9c8-0002a5d5c51b15
858346Zipsor 25 MG Oral CapsuleSYc982eca0-fc41-11e1-a9c8-0002a5d5c51b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13913-008-1113913000811100 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-11) 2009-06-160000-00-00NoNoCurrent
13913-008-1213913000812120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12) 2015-12-010000-00-00NoNoCurrent
13913-008-94139130008941 BLISTER PACK in 1 CARTON (13913-008-94) > 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2009-06-160000-00-00NoNoCurrent