Diclofenac sodium

Product NDC
83008-019
11-digit product format
830080019
Labeler code
83008
Product ID
83008-019_43a5d516-ca87-46fb-9313-30c48d174a49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Quality Care Products, LLC
Application
ANDA212506
Marketing category
ANDA
Marketing start
2023-05-02
Marketing end
2027-05-31
Substance
DICLOFENAC SODIUM
Active strength
20 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
QTG126297QDICLOFENAC SODIUM15307-79-6DICLOFENAC SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-019-12830080019121 BOTTLE, PUMP in 1 CARTON (83008-019-12) / 112 g in 1 BOTTLE, PUMP2023-05-022027-05-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Diclofenac sodiumQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL4