NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3538Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3538Add 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
70518-3538-3705183538037051835380390 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3)Marketed from Apr 6, 2023

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 Potassium
Generic name (nonproprietary)
diclofenac potassium
Active ingredients
Diclofenac potassium — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215585
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 70518-3538_5472ba66-47b6-8776-e063-6294a90abc82SPL ID 5472ba66-47b6-8776-e063-6294a90abc82SPL set ID c4976d69-ca06-4263-9240-6fd8b44a9b6dRxCUI 855942UNII L4D5UA6CB4

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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470518353803 followed by a unit qualifier and the quantity

Package 70518-3538-03. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: for treatment of primary dysmenorrhea for relief of mild to moderate pain for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3538

What is NDC 70518-3538?
70518-3538 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Diclofenac Potassium.
What is the active ingredient?
Diclofenac potassium.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. 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 Potassium?
67 other product NDCs are listed under this name. See all Diclofenac Potassium 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 Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diclofenac PotassiumDiclofenac potassium 75 mg/1Tablet, CoatedOralAdvagen Pharma Ltd72888-20372888-0203-0072888-0203-0172888-0203-05+1 more
Diclofenac Potassiumdiclofenac potassium, film coatedDiclofenac potassium 50 mg/1TabletOralAmerisyn LLC87564-01187564-0011-10
Diclofenac Potassiumdiclofenac potassium, film coatedDiclofenac potassium 50 mg/1TabletOralVICI Pharmaceuticals, Inc87528-00187528-0001-10
Diclofenac Potassiumdiclofenac potassium 25 mgDiclofenac potassium 25 mg/1Capsule, Liquid filledOralPureTek Corporation59088-13159088-0131-73
Diclofenac PotassiumDiclofenac potassium 50 mg/1Powder, For solutionOralUmedica Laboratories USA Inc.60290-06160290-0061-0160290-0061-02
Diclofenac PotassiumDiclofenac potassium 50 mg/1Powder, For solutionOralNivagen Pharmaceuticals, Inc.75834-33875834-0338-0175834-0338-02
Diclofenac Potassiumdiclofenac potassium tabletsDiclofenac potassium 25 mg/1Tablet, Film coatedOralNIVAGEN PHARMACEUTICALS, INC.75834-33775834-0337-3075834-0337-60
Diclofenac Potassiumdiclofenac potassium, film coatedDiclofenac potassium 25 mg/1TabletOralHappy Robin, LLC87127-80287127-0802-60
Diclofenac PotassiumDiclofenac potassium 25 mg/1Capsule, Liquid filledOralLifsa Drugs LLC72336-43272336-0432-12
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-841168788-8411-0168788-8411-0368788-8411-06+1 more

All 68 Diclofenac Potassium NDCs

Other NDCs under ANDA 215585

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

FDA NDC Directory listings under ANDA 215585
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralAvKARE42291-042
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralIngenus Pharmaceuticals, LLC50742-279
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8697
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2530

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