diclofenac sodium delayed release

Generic: diclofenac sodium

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium delayed release
Generic Name diclofenac sodium
Labeler remedyrepack inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0627
Product ID 70518-0627_47fa96a1-8c4a-46a5-e063-6294a90a9a80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075185
Listing Expiration 2027-12-31
Marketing Start 2017-07-18

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] decreased prostaglandin production [pe] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705180627
Hyphenated Format 70518-0627

Supplemental Identifiers

RxCUI
855926
UNII
QTG126297Q

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name diclofenac sodium delayed release (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA075185 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-1)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-2)
source: ndc

Packages (2)

70518-0627-1 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-1) 70518-0627-2 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-2)

Ingredients (1)

diclofenac sodium (75 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium Delayed Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47fa96a1-8c4a-46a5-e063-6294a90a9a80", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["10991fe6-fafd-49af-9684-83b447c19c67"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-1)", "package_ndc": "70518-0627-1", "marketing_start_date": "20171023"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-2)", "package_ndc": "70518-0627-2", "marketing_start_date": "20191111"}], "brand_name": "Diclofenac Sodium Delayed Release", "product_id": "70518-0627_47fa96a1-8c4a-46a5-e063-6294a90a9a80", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "70518-0627", "generic_name": "Diclofenac Sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "brand_name_suffix": "Delayed Release", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "20170718", "listing_expiration_date": "20271231"}