Over-the-counter drug · ANDA

Diclofenac sodium (Diclofenac) NDC 73469-2053

Diclofenac sodium 10 mg/g · Gel · Topical · Scholl's Wellness Company

NDC codes

FDA NDC Directory
Product NDC (as listed)73469-2053Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73469-2053Add 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
73469-2053-173469205301734692053011 TUBE in 1 CARTON (73469-2053-1) / 100 g in 1 TUBEMarketed from Oct 30, 2020
73469-2053-873469205308734692053081 TUBE in 1 CARTON (73469-2053-8) / 50 g in 1 TUBEMarketed from Oct 30, 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
Active ingredients
Diclofenac sodium — 10 mg/g
Dosage form
Gel
Route
Topical
Labeler
Scholl's Wellness CompanyNDC labeler code 73469
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208077
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 73469-2053_3f399f7d-a801-4fce-9c3a-7e3a4d6e2507SPL ID 3f399f7d-a801-4fce-9c3a-7e3a4d6e2507SPL set ID 8dcbce69-945b-4913-a279-ee10871f6580RxCUI 855633UNII 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

N473469205301 followed by a unit qualifier and the quantity

Package 73469-2053-01. 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)

Use(s)  for the temporary relief of arthritis pain ONLY in the following areas  head, wrist, elbow (upper body areas)  foot, ankle, knee (lower body areas)  this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73469-2053

What is NDC 73469-2053?
73469-2053 is the product NDC for Diclofenac sodium (diclofenac), Diclofenac sodium 10 mg/g gel, listed with the FDA by Scholl's Wellness Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac sodium (Diclofenac).
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Scholl's Wellness Company, NDC labeler code 73469. 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?
241 other product NDCs are listed under this name. See all Diclofenac sodium 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac Sodiumdiclofenac sodium topical gel, 1%Diclofenac sodium 10 mg/gGelTopicalIPG Pharmaceuticals, inc.71085-08471085-0084-03
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalTarget Corporation11673-02811673-0028-1011673-0028-15
Diclofenac SodiumDiclofenac sodium 75 mg/1Tablet, Delayed releaseOralNorthwind Health Company, LLC82868-11482868-0114-30
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-413568788-4135-01
Diclofenac SodiumDiclofenac sodium 100 mg/1Tablet, Film coated, Extended releaseOralAurobindo Pharma Limited84386-10384386-0103-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-469470518-4694-00
Diclofenac sodiumDiclofenac sodium 30 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-411868788-4118-01
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPreferred Pharmaceuticals Inc.68788-433568788-4335-01
Diclofenac SodiumDiclofenac sodium 25 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08260290-0082-01
Diclofenac SodiumDiclofenac sodium 50 mg/1Tablet, Delayed releaseOralUmedica Laboratories USA Inc.60290-08360290-0083-0160290-0083-0260290-0083-03+1 more

All 242 Diclofenac sodium NDCs

Other NDCs under ANDA 208077

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

FDA NDC Directory listings under ANDA 208077
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac sodiumdiclofenacDiclofenac sodium 10 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-2053
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalP & L Development, LLC59726-012
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalAmerisourceBergen (Good Neighbor Pharmacy) 4612246122-752
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalSportpharm LLC85766-136
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS PHARMACY, INC51316-073
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalBest Choice (Valu Merchandisers Company)63941-812
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalSafeway, Inc.21130-028
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalQUALITY CHOICE (Chain Drug Marketing Association)83324-306
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS PHARMACY, INC51316-012
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWalgreens0363-1210
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalChain Drug Consortium, LLC68016-171
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCostco Wholesale63981-211
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCARDINAL HEALTH 110, LLC. DBA LEADER 7000070000-0555
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalRugby Laboratories0536-1294
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalFamily Dollar (FAMILY WELLNESS)55319-969
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS Pharmacy69842-974
Diclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-269
Salonpasdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalHisamitsu America, Inc.55328-801

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