NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2239Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2239Add 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
68071-2239-1680712239011 TUBE in 1 CARTON (68071-2239-1) / 100 g in 1 TUBEMarketed from Aug 17, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/g
Dosage form
Gel
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210986
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 68071-2239_2ac18f20-1e36-590d-e063-6294a90ac453SPL ID 2ac18f20-1e36-590d-e063-6294a90ac453SPL set ID ad193f94-f8d0-8482-e053-2995a90a35a4RxCUI 855633UNII QTG126297QUPC 0368071223910

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

N468071223901 followed by a unit qualifier and the quantity

Package 68071-2239-01. 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 topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder. (14.1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210986

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

FDA NDC Directory listings under ANDA 210986
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalDr. Reddy's Laboratories Inc.43598-977
Crcle Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel 1%Diclofenac sodium 10 mg/gGelTopicalInnovus Pharmaceuticals Inc.57483-596
Gencare-Arthritis Pain Reliefdiclofenac sodiumDiclofenac sodium .01 g/gGelTopicalPioneer Life Sciences, LLC72090-017
Diclofenac Sodiumdiclofenac sodium 1%Diclofenac sodium 10 mg/gGelTopicalSportpharm LLC85766-240
Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalKroger Company30142-025
Diclofenac Sodium Topical Gel 1%diclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalWalgreens Company0363-7065
Dolo-NeuroBion Arthritis Paindiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalBENARD INDUSTRIES INC55959-123
Diclofenac Sodiumdiclofenac sodium 1%Diclofenac sodium 10 mg/gGelTopicalAsclemed USA, Inc.76420-691
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalAdvanced Rx Pharmacy of Tennessee, LLC80425-0233
Aspercreme Arthritisdiclofenac sodiumDiclofenac sodium .01 g/gGelTopicalChattem, Inc.41167-0571
Diclofenac Sodium GelDiclofenac sodium 10 mg/gGelTopicalDirect_Rx72189-479
Curist Arthritis Reliefdiclofenac sodiumDiclofenac sodium 1 g/100gGelTopicalLittle Pharma, Inc.72559-020
Arthritis Paindiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalStrategic Sourcing Services, LLC70677-1125
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalBluePoint Laboratories68001-621
Diclofenac Sodiumdiclofenac sodium 1%Diclofenac sodium 10 mg/gGelTopicalSOLA Pharmaceuticals70512-106
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalEncube Ethicals, Inc.21922-044
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalProficient Rx LP71205-747
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalNuCare Pharmaceuticals,Inc.68071-3483
Diclofenac Sodiumdiclofenac sodium topical gel, 1%,Diclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals, Inc.68788-7772
Diclofenac Sodium Topical 1%diclofenac sodiumDiclofenac sodium 1 mg/100gGelTopicalYYBA CORP73581-104

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