diclofenac

Generic: diclofenac sodium

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

Drug Facts

Product Profile

Brand Name diclofenac
Generic Name diclofenac sodium
Labeler altaire pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

diclofenac sodium 1 mg/mL

Manufacturer
Altaire Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59390-149
Product ID 59390-149_0561ff06-43b4-493e-93f7-b778fc829036
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203383
Listing Expiration 2026-12-31
Marketing Start 2015-11-16

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 59390149
Hyphenated Format 59390-149

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 (source: ndc)
Generic Name diclofenac sodium (source: ndc)
Application Number ANDA203383 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

59390-149-02 1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) / 2.5 mL in 1 BOTTLE, DROPPER 59390-149-05 1 BOTTLE, DROPPER in 1 CARTON (59390-149-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

diclofenac sodium (1 mg/mL)

Linked Drug Pages (1)

Diclofenac ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0561ff06-43b4-493e-93f7-b778fc829036", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["854801"], "spl_set_id": ["5372866a-dab3-45c8-8c2a-755ca36c1791"], "manufacturer_name": ["Altaire Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (59390-149-02)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "59390-149-02", "marketing_start_date": "20151116"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (59390-149-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "59390-149-05", "marketing_start_date": "20151116"}], "brand_name": "Diclofenac", "product_id": "59390-149_0561ff06-43b4-493e-93f7-b778fc829036", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Decreased Prostaglandin Production [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "59390-149", "generic_name": "Diclofenac Sodium", "labeler_name": "Altaire Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "1 mg/mL"}], "application_number": "ANDA203383", "marketing_category": "ANDA", "marketing_start_date": "20151116", "listing_expiration_date": "20261231"}