Over-the-counter drug · ANDA

arthritis pain relieving (Diclofenac sodium) NDC 41250-674

Diclofenac sodium 10 mg/g · Gel · Topical · Meijer Distribution Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)41250-674Labeler and product segments. Claims need a package NDC.
Product NDC at billing width41250-0674Add 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
41250-674-0141250067401412500674011 TUBE in 1 CARTON (41250-674-01) / 100 g in 1 TUBEMarketed from Sep 1, 2020
41250-674-0241250067402412500674021 TUBE in 1 CARTON (41250-674-02) / 50 g in 1 TUBEMarketed from Mar 16, 2021
41250-674-0341250067403412500674031 TUBE in 1 CARTON (41250-674-03) / 150 g in 1 TUBEMarketed from Jan 21, 2021

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)
arthritis pain relieving
Generic name (nonproprietary)
diclofenac sodium
Active ingredients
Diclofenac sodium — 10 mg/g
Dosage form
Gel
Route
Topical
Labeler
Meijer Distribution IncNDC labeler code 41250
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211253
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 41250-674_affacda5-9d7a-4133-b4d3-7d05b40308b1SPL ID affacda5-9d7a-4133-b4d3-7d05b40308b1SPL set ID d46a4841-2f86-4e0e-ac79-9b1444ed4f79RxCUI 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

N441250067401 followed by a unit qualifier and the quantity

Package 41250-0674-01. 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)

Uses • for the temporary relief of arthritis pain ONLY in the following areas: • hand, 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 41250-674

What is NDC 41250-674?
41250-674 is the product NDC for arthritis pain relieving (diclofenac sodium), Diclofenac sodium 10 mg/g gel, listed with the FDA by Meijer Distribution Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
arthritis pain relieving (Diclofenac sodium).
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Meijer Distribution Inc, NDC labeler code 41250. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for arthritis pain relieving?
3 other product NDCs are listed under this name. See all arthritis pain relieving 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 arthritis pain relieving NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Arthritis Pain Relievingdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalMeijer, Inc.79481-049979481-0499-0079481-0499-0179481-0499-02
Arthritis Pain Relievingdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWalgreen Company0363-300300363-3003-0200363-3003-03
arthritis pain relievingdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWalgreen Company0363-512300363-5123-0200363-5123-03

Other NDCs under ANDA 211253

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

FDA NDC Directory listings under ANDA 211253
ProductStrengthForm · routeLabelerProduct NDC
good sense arthritis paindiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalA-S Medication Solutions50090-7250
arthritis pain relievingdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWalgreen Company0363-5123
Motrin Arthritis Paindiclofenac sodiumDiclofenac sodium 9.3 mg/gGelTopicalKenvue Brands LLC50580-574
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalNuCare Pharmaceuticals,Inc.68071-3456
Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalPublix Super Markets Inc56062-471
Equate Arthritis Paindiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWALMART INC.79903-391
Arthritis Pain Reliefdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-517
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-953
topcare athritis pain relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalTopco Associates LLC36800-526
CareOne arthritis pain reliefdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalAmerican Sales Company41520-788
arthritis pain relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalPublix Super Markets Inc56062-878
Aspercreme Arthritisdiclofenac sodiumDiclofenac sodium .01 g/gGelTopicalChattem, Inc.41167-0573
Arthritis Pain Relievingdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalWalgreen Company0363-3003
Diclofenac SodiumDiclofenac sodium 10 mg/gGelTopicalCVS Pharmacy69842-729
good sense arthritis paindiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalL. Perrigo Company0113-1189
basic care arthritis paindiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalAmazon.com Services LLC72288-870
berkley and jensen arthritis paindiclofenac sodium—KitBJWC68391-205
Members Mark Arthritis Pain Relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalSam's West Inc68196-523
Dg Health Arthritis Paindiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalDolgencorp Inc55910-926
members mark arthritis pain relieverdiclofenac sodiumDiclofenac sodium 10 mg/gGelTopicalSam's West Inc68196-870

Showing 20 of 39.

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