NDC 55700-834

Diclofenac Sodium Delayed Release

Diclofenac Sodium

Diclofenac Sodium Delayed Release is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Diclofenac Sodium.

Product ID55700-834_46f2b119-efcd-497d-aefc-74029d190313
NDC55700-834
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium Delayed Release
Generic NameDiclofenac Sodium
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2020-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA075185
Labeler NameQuality Care Products, LLC
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength75 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55700-834-20

20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55700-834-20)
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55700-834-60 [55700083460]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-03

NDC 55700-834-30 [55700083430]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-03

NDC 55700-834-20 [55700083420]

Diclofenac Sodium Delayed Release TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA075185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM75 mg/1

Pharmacological Class

  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

NDC Crossover Matching brand name "Diclofenac Sodium Delayed Release" or generic name "Diclofenac Sodium"

NDCBrand NameGeneric Name
68071-3184Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
68071-4231Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
68071-4117Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
68788-8952Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
68788-9806Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70518-0627Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70518-0756Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70518-1104Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70934-165Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70934-122Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
70934-157Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
71335-0357Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
71335-0481Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
10544-188Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
10544-189Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
42254-059Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
43063-694Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
43063-693Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
50090-0542Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
50090-0543Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
50090-0545Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
50436-1022Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
53002-5360Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
53002-5370Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
60760-154Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
61145-101Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
61442-102Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
60760-153Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
61442-101Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
61442-103Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
61145-102Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63187-222Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63629-1012Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63629-1011Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63629-1534Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63629-7654Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
63629-7655Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
68071-4934Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
0440-6396Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
45865-999Diclofenac Sodium Delayed ReleaseDiclofenac Sodium Delayed Release
0280-0039Aleve Arthritis Pain GelDiclofenac Sodium
0115-1483Diclofenac SodiumDiclofenac Sodium
0168-0803DICLOFENAC SODIUMdiclofenac sodium
0168-0844DICLOFENAC SODIUMdiclofenac sodium
0228-2550Diclofenac SodiumDiclofenac Sodium
0228-2551Diclofenac SodiumDiclofenac Sodium
0363-1210Diclofenac sodiumDiclofenac sodium
0363-1871diclofenac sodiumdiclofenac sodium
0378-0355Diclofenac SodiumDiclofenac Sodium
0378-6280Diclofenac Sodiumdiclofenac sodium
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.