NDC codes

FDA NDC Directory
Product NDC (as listed)0536-1294Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00536-1294Add 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
0536-1294-3100536129431005361294311 TUBE in 1 CARTON (0536-1294-31) / 150 g in 1 TUBEMarketed from Sep 14, 2020
0536-1294-3400536129434005361294341 TUBE in 1 CARTON (0536-1294-34) / 50 g in 1 TUBEMarketed from Sep 14, 2020
0536-1294-9700536129497005361294971 TUBE in 1 CARTON (0536-1294-97) / 100 g in 1 TUBEMarketed from Sep 14, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/g
Dosage form
Gel
Route
Topical
Labeler
Rugby LaboratoriesNDC labeler code 0536
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 0536-1294_8b734e52-fc53-489b-97a3-bea23f008d40SPL ID 8b734e52-fc53-489b-97a3-bea23f008d40SPL set ID 95f3c70c-eded-4d24-b9b0-cfa0b7902d6eRxCUI 855633UNII QTG126297QUPC 0305361294977

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

N400536129431 followed by a unit qualifier and the quantity

Package 00536-1294-31. 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 0536-1294

What is NDC 0536-1294?
0536-1294 is the product NDC for Diclofenac sodium, Diclofenac sodium 10 mg/g gel, listed with the FDA by Rugby Laboratories. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac sodium.
What is the active ingredient?
Diclofenac sodium.
Who is the labeler?
Rugby Laboratories, NDC labeler code 0536. 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 sodiumdiclofenacDiclofenac sodium 10 mg/gGelTopicalScholl's Wellness Company73469-2053
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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