diclofenac sodium 1.5%

Generic: diclofenac sodium topical

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

Drug Facts

Product Profile

Brand Name diclofenac sodium 1.5%
Generic Name diclofenac sodium topical
Labeler sola pharmaceuticals
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

diclofenac sodium 16.05 mg/mL

Manufacturer
SOLA Pharmaceuticals

Identifiers & Regulatory

Product NDC 70512-038
Product ID 70512-038_457256fd-2abe-2c5a-e063-6394a90a84c0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204132
Listing Expiration 2027-12-31
Marketing Start 2021-06-04

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 70512038
Hyphenated Format 70512-038

Supplemental Identifiers

RxCUI
857700
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 1.5% (source: ndc)
Generic Name diclofenac sodium topical (source: ndc)
Application Number ANDA204132 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 16.05 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70512-038-05) / 150 mL in 1 BOTTLE
source: ndc

Packages (1)

70512-038-05 1 BOTTLE in 1 CARTON (70512-038-05) / 150 mL in 1 BOTTLE

Ingredients (1)

diclofenac sodium (16.05 mg/mL)

Linked Drug Pages (1)

Diclofenac Sodium 1.5% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "457256fd-2abe-2c5a-e063-6394a90a84c0", "openfda": {"unii": ["QTG126297Q"], "rxcui": ["857700"], "spl_set_id": ["c3f33952-44a8-71b2-e053-2a95a90abda2"], "manufacturer_name": ["SOLA Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70512-038-05)  / 150 mL in 1 BOTTLE", "package_ndc": "70512-038-05", "marketing_start_date": "20210604"}], "brand_name": "Diclofenac Sodium 1.5%", "product_id": "70512-038_457256fd-2abe-2c5a-e063-6394a90a84c0", "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": "70512-038", "generic_name": "Diclofenac Sodium Topical", "labeler_name": "SOLA Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Diclofenac Sodium 1.5%", "active_ingredients": [{"name": "DICLOFENAC SODIUM", "strength": "16.05 mg/mL"}], "application_number": "ANDA204132", "marketing_category": "ANDA", "marketing_start_date": "20210604", "listing_expiration_date": "20271231"}