diclofenac sodium

Generic: diclofenac sodium

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler a-s medication solutions
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

diclofenac sodium 50 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0538
Product ID 50090-0538_a0f702bc-8f8e-4a74-868d-76243d836f80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074514
Listing Expiration 2027-12-31
Marketing Start 1996-03-26

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 500900538
Hyphenated Format 50090-0538

Supplemental Identifiers

RxCUI
855906
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 (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA074514 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-0)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-2)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-5)
source: ndc

Packages (3)

50090-0538-0 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-0) 50090-0538-2 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-2) 50090-0538-5 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-5)

Ingredients (1)

diclofenac sodium (50 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": "a0f702bc-8f8e-4a74-868d-76243d836f80", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["855906"], "spl_set_id": ["b74be49d-74ff-491b-962b-0edd3a57cbc9"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-0)", "package_ndc": "50090-0538-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-2)", "package_ndc": "50090-0538-2", "marketing_start_date": "20160629"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-5)", "package_ndc": "50090-0538-5", "marketing_start_date": "20160629"}], "brand_name": "Diclofenac Sodium", "product_id": "50090-0538_a0f702bc-8f8e-4a74-868d-76243d836f80", "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": "50090-0538", "generic_name": "Diclofenac Sodium", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "50 mg/1"}], "application_number": "ANDA074514", "marketing_category": "ANDA", "marketing_start_date": "19960326", "listing_expiration_date": "20271231"}