NDC codes

FDA NDC Directory
Product NDC (as listed)72189-379Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0379Add 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
72189-379-01721890379011 g in 1 TUBE (72189-379-01)Marketed from Sep 8, 2022

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 Gel
Generic name (nonproprietary)
diclofenac sodium gel
Active ingredients
Diclofenac sodium — 30 mg/g
Dosage form
Gel
Route
Topical
Labeler
Direct_RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208301
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 72189-379_4d3a653e-054e-4554-e063-6294a90a1239SPL ID 4d3a653e-054e-4554-e063-6294a90a1239SPL set ID e82e4d34-bdaa-b950-e053-2995a90a29f1RxCUI 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

N472189037901 followed by a unit qualifier and the quantity

Package 72189-0379-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-379

What is NDC 72189-379?
72189-379 is the product NDC for Diclofenac Sodium Gel, Diclofenac sodium 30 mg/g gel, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac Sodium Gel.
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diclofenac Sodium Gel?
2 other product NDCs are listed under this name. See all Diclofenac Sodium Gel NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diclofenac Sodium Gel NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodium GelDiclofenac sodium 10 mg/gGelTopicalDirect_Rx72189-47972189-0479-01
Diclofenac Sodium GelDiclofenac sodium 30 mg/gGelTopicalDirect_Rx72189-47372189-0473-01

Other NDCs under ANDA 208301

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

FDA NDC Directory listings under ANDA 208301
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalAdvanced Rx Pharmacy of Tennessee, LLC80425-0236
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalHAWAII REPACK, INC85534-0089
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalREMEDYREPACK INC.70518-3315
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-9435
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalProficient Rx LP82804-052
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalNuCare Pharmaceuticals,Inc.68071-3516
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalGLENMARK PHARMACEUTICALS INC., USA68462-355
Diclofenac SodiumDiclofenac sodium 30 mg/gGelTopicalAsclemed USA, Inc.76420-132

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