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NDC 61919-0686-20 DICLOFENAC SODIUM 75 mg/1 Details
DICLOFENAC SODIUM 75 mg/1
DICLOFENAC SODIUM 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.
MedlinePlus Drug Summary
Diclofenac capsules (Zipsor, Zorvolex) and tablets (Cataflam) are used to relieve mild to moderate pain. Diclofenac extended-release tablets (Voltaren XR), tablets (Cataflam), and delayed-release tablets (available generically) are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Diclofenac extended-release tablets and delayed-release tablets are also used to treat ankylosing spondylitis (arthritis that mainly affects the spine). Diclofenac tablets (Cataflam) are also used to treat painful menstrual periods. Diclofenac solution (Cambia) is used to treat migraine headaches in adults, but cannot be used to prevent migraines or to treat other types of headaches. Diclofenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 61919-0686-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diclofenac
Product Information
NDC | 61919-0686 |
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Product ID | 61919-686_3104cae3-5e37-6c6e-e054-00144ff88e88 |
Associated GPIs | 66100007200630 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | DICLOFENAC SODIUM |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | DECLOFENAC SODIUM |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, DELAYED RELEASE |
Route | ORAL |
Active Ingredient Strength | 75 |
Active Ingredient Units | mg/1 |
Substance Name | DICLOFENAC SODIUM |
Labeler Name | DIRECT RX |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA077863 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 61919-0686-20 (61919068620)
NDC Package Code | 61919-686-20 |
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Billing NDC | 61919068620 |
Package | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-686-20) |
Marketing Start Date | 2016-03-22 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3104cae3-5e36-6c6e-e054-00144ff88e88 Details
INGREDIENTS AND APPEARANCE
DICLOFENAC SODIUM
declofenac sodium tablet, delayed release |
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Labeler - DIRECT RX (079254320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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DIRECT RX | 079254320 | repack(61919-686) |