NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3718Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3718Add 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
68071-3718-36807137180330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3718-3)Marketed from Nov 11, 2024

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075463
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers
Product ID 68071-3718_26a8f7fc-92d9-9d82-e063-6394a90aa3afSPL ID 26a8f7fc-92d9-9d82-e063-6394a90aa3afSPL set ID 26a8f723-2a8e-8a5a-e063-6394a90a7baeRxCUI 855942UNII L4D5UA6CB4UPC 0368071371833

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

N468071371803 followed by a unit qualifier and the quantity

Package 68071-3718-03. 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)

Other NDCs under ANDA 075463

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

FDA NDC Directory listings under ANDA 075463
ProductStrengthForm · routeLabelerProduct NDC
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralArchis Pharma LLC72819-151
Diclofenac PotassiumDiclofenac potassium 50 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals, Inc.10135-806

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