diclofenac sodium

Generic: diclofenac sodium

Labeler: sola pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler sola pharmaceuticals, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 75 mg/1

Manufacturer
SOLA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70512-784
Product ID 70512-784_43cedf6d-7cca-c35c-e063-6294a90afd04
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075185
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

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 70512784
Hyphenated Format 70512-784

Supplemental Identifiers

RxCUI
855926
UPC
0370512784607
UNII
QTG126297Q

Packaging Origin

Original Packager
true

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 (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
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70512-784-60)
source: ndc

Packages (1)

70512-784-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70512-784-60)

Ingredients (1)

diclofenac sodium (75 mg/1)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43cedf6d-7cca-c35c-e063-6294a90afd04", "openfda": {"upc": ["0370512784607"], "unii": ["QTG126297Q"], "rxcui": ["855926"], "spl_set_id": ["b8072af2-9940-4827-9fbd-de46ad8bf929"], "manufacturer_name": ["SOLA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (70512-784-60)", "package_ndc": "70512-784-60", "marketing_start_date": "20251114"}], "brand_name": "Diclofenac Sodium", "product_id": "70512-784_43cedf6d-7cca-c35c-e063-6294a90afd04", "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": "70512-784", "generic_name": "Diclofenac Sodium", "labeler_name": "SOLA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "75 mg/1"}], "application_number": "ANDA075185", "marketing_category": "ANDA", "marketing_start_date": "20251114", "listing_expiration_date": "20261231"}