NDC codes

FDA NDC Directory
Product NDC (as listed)64380-841Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64380-0841Add 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
64380-841-0664380084106100 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-841-06)Marketed from Sep 20, 2022
64380-841-1164380084111120 CAPSULE, LIQUID FILLED in 1 BOTTLE (64380-841-11)Marketed from Dec 28, 2024

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 — 25 mg/1
Dosage form
Capsule, Liquid filled
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210078
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 64380-841_556344ea-371c-26d3-e063-6294a90abf5eSPL ID 556344ea-371c-26d3-e063-6294a90abf5eSPL set ID 2184805c-b9b3-4be8-8726-4ce1b1197477RxCUI 858342UNII L4D5UA6CB4UPC 0364380841067, 0364380841111

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

N464380084106 followed by a unit qualifier and the quantity

Package 64380-0841-06. 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)

Diclofenac Potassium Capsules are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. (1) Diclofenac Potassium Capsules are non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years age and older. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210078

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

FDA NDC Directory listings under ANDA 210078
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac PotassiumDiclofenac potassium 25 mg/1Capsule, Liquid filledOralChartwell RX, LLC62135-469
Diclofenac PotassiumDiclofenac potassium 25 mg/1Capsule, Liquid filledOralLifsa Drugs LLC72336-432
diclofenac potassiumDiclofenac potassium 25 mg/1Capsule, Liquid filledOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-840
Diclofenac Potassiumdiclofenac potassium 25 mgDiclofenac potassium 25 mg/1Capsule, Liquid filledOralPureTek Corporation59088-131

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