NDC codes

FDA NDC Directory
Product NDC (as listed)43063-848Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0848Add 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
43063-848-21430630848214306308482121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-21)Marketed from Apr 12, 2018
43063-848-30430630848304306308483030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-30)Marketed from Apr 12, 2018

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)
Diclofenac Potassium
Generic name (nonproprietary)
diclofenac potassium
Active ingredients
Diclofenac potassium — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075219
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 43063-848_2fc3b270-b101-5a08-e063-6394a90a7fd2SPL ID 2fc3b270-b101-5a08-e063-6394a90a7fd2SPL set ID 08e41a9d-644c-4ac6-aba3-38d7c3f36d36RxCUI 855942UNII L4D5UA6CB4UPC 0343063848210

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

N443063084821 followed by a unit qualifier and the quantity

Package 43063-0848-21. 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 43063-848

What is NDC 43063-848?
43063-848 is the product NDC for Diclofenac Potassium, Diclofenac potassium 50 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 2 package NDCs, 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 075219

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

FDA NDC Directory listings under ANDA 075219
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-0948
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4108
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.66267-070
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8411

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