Diclofenac Sodium NDC 68071-3556

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-3556Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-3556Add 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 NDC	11-digit (billing)	Package	Copy
68071-3556-7	68071355607	7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68071-3556-7)Marketed from Dec 22, 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 Sodium
Generic name (nonproprietary): diclofenac sodium
Active ingredients: Diclofenac sodium — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076201
Marketing start: Nov 6, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 68071-3556_2d3fc030-5d55-2acd-e063-6294a90a11abSPL ID 2d3fc030-5d55-2acd-e063-6294a90a11abSPL set ID 0d1d19e5-4ffe-af95-e063-6394a90a7abfRxCUI 855657UNII QTG126297QUPC 0368071355673
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

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

N468071355607 followed by a unit qualifier and the quantity

Package 68071-3556-07. 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 Feb 3, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium extended release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . Diclofenac sodium extended-release tablets are indicated: • 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 076201

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

FDA NDC Directory listings under ANDA 076201
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals, LLC.	68071-3720
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Extended releaseOral	Edenbridge Pharmaceuticals LLC.	42799-953
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Extended releaseOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-953