diclofenac sodium

Generic: diclofenac sodium

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name diclofenac sodium
Generic Name diclofenac sodium
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

diclofenac sodium 1 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-014
Product ID 61314-014_202278f8-31f7-4c24-ae96-8065430d6a7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078031
Listing Expiration 2026-12-31
Marketing Start 2008-02-14

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 61314014
Hyphenated Format 61314-014

Supplemental Identifiers

RxCUI
854801
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 ANDA078031 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLE
source: ndc

Packages (2)

61314-014-05 1 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLE 61314-014-25 1 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLE

Ingredients (1)

diclofenac sodium (1 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "202278f8-31f7-4c24-ae96-8065430d6a7d", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["854801"], "spl_set_id": ["52d22a6b-3acd-4694-9df5-8cfa9cc2bb2b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-014-05)  / 5 mL in 1 BOTTLE", "package_ndc": "61314-014-05", "marketing_start_date": "20180214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-014-25)  / 2.5 mL in 1 BOTTLE", "package_ndc": "61314-014-25", "marketing_start_date": "20180214"}], "brand_name": "Diclofenac Sodium", "product_id": "61314-014_202278f8-31f7-4c24-ae96-8065430d6a7d", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "61314-014", "generic_name": "Diclofenac Sodium", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "1 mg/mL"}], "application_number": "ANDA078031", "marketing_category": "ANDA", "marketing_start_date": "20080214", "listing_expiration_date": "20261231"}