Diclofenac Sodium Extended-Release
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USP
Approved
Approval ID
688fa1d0-6e17-4191-8618-8f62bc7765d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diclofenac Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-040
Application NumberANDA075910
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification
INGREDIENTS (11)
colloidal silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Diclofenac SodiumActive
Quantity: 100 mg in 1 1
Code: QTG126297Q
Classification: ACTIM
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
hypromelloseInactive
Code: 3NXW29V3WO
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT