NDC 61919-074

Diclofenac Sodium D/R

Diclofenac Sodium D/r

Diclofenac Sodium D/R is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Diclofenac Sodium.

• Product ID: 61919-074_3fdaa3f6-dd9d-6a74-e054-00144ff88e88
• NDC: 61919-074
• Product Type: Human Prescription Drug
• Proprietary Name: Diclofenac Sodium D/R
• Generic Name: Diclofenac Sodium D/r
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075185
• Labeler Name: Direct RX
• Substance Name: DICLOFENAC SODIUM
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-074-30

30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-074-30)

• Marketing Start Date: 2014-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-074-60 [61919007460]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075185
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

NDC 61919-074-30 [61919007430]

Diclofenac Sodium D/R TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075185
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-01-01

Drug Details

Active Ingredients

Ingredient	Strength
DICLOFENAC SODIUM	50 mg/1

OpenFDA Data

• SPL SET ID: 2ae3c1e2-f053-4efb-9597-eeac4998d23f
• Manufacturer:
  • Direct RX
• UNII:
  • QTG126297Q
• RxNorm Concept Unique ID - RxCUI:
  • 855926
  • 855906

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 D/R" or generic name "Diclofenac Sodium D/r"

NDC	Brand Name	Generic Name
61919-074	Diclofenac Sodium D/R	Diclofenac Sodium D/R
61919-075	Diclofenac Sodium D/R	Diclofenac Sodium D/R
61919-060	VOLTAREN	DICLOFENAC SODIUM D/R