NDC codes

FDA NDC Directory
Product NDC (as listed)72189-040Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0040Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72189-040-01721890040011 g in 1 TUBE (72189-040-01)Marketed from Oct 8, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Diclofenac Sodium
Generic name (nonproprietary)
diclofenac sodium
Active ingredients
Diclofenac sodium — 30 mg/g
Dosage form
Gel
Route
Topical
Labeler
Direct_Rx
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206298
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 72189-040_4d27e658-ecb1-90e3-e063-6294a90ad00fSPL ID 4d27e658-ecb1-90e3-e063-6294a90ad00fSPL set ID 946b3799-2d56-12a5-e053-2a95a90aeba0RxCUI 855642UNII QTG126297Q

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472189004001 followed by a unit qualifier and the quantity

Package 72189-0040-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206298

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206298
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalProficient Rx LP71205-538
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalSun Pharmaceutical Industries, Inc.51672-1363
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalAsclemed USA, Inc.76420-275
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalAdvanced Rx Pharmacy of Tennessee, LLC80425-0235
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalNuCare Pharmaceuticals,Inc.68071-3688
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-8236
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-4118

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