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NDC 43386-0016-61 DICLOFENAC SODIUM 16.05 mg/mL Details

DICLOFENAC SODIUM 16.05 mg/mL

DICLOFENAC SODIUM is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is DICLOFENAC SODIUM.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) diclofenac topical gel (Voltaren Arthritis Pain) is used to relieve pain from arthritis in certain joints such as those of the knees, ankles, feet, elbows, wrists, and hands. Prescription diclofenac topical solution (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the body's production of a substance that causes pain. Diclofenac is also available as a 3% gel (Solaraze; generic) that is applied to the skin to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). This monograph only gives information about nonprescription diclofenac topical gel (Voltaren Arthritis Pain) for arthritis and prescription topical solution (Pennsaid) for osteoarthritis of the knee. If you are using diclofenac gel (Solaraze, generic) for actinic keratosis, read the monograph entitled diclofenac topical (actinic keratosis).

Related Packages: 43386-0016-61
Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Diclofenac Topical (arthritis pain)

Product Information

NDC	43386-0016
Product ID	43386-016_d85013c6-896b-4d20-976c-3a583ab4ba7c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DICLOFENAC SODIUM
Proprietary Name Suffix	n/a
Non-Proprietary Name	DICLOFENAC SODIUM
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	16.05
Active Ingredient Units	mg/mL
Substance Name	DICLOFENAC SODIUM
Labeler Name	Lupin Pharmaceuticals,Inc.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA205878
Listing Certified Through	2024-12-31

Package

NDC 43386-0016-61 (43386001661)

Pricing Information	N/A
NDC Package Code	43386-016-61
Billing NDC	43386001661
Package	150 mL in 1 BOTTLE (43386-016-61)
Marketing Start Date	2015-12-09
NDC Exclude Flag	N