Diclofenac Sodium ER (diclofenac sodium) NDC 80425-0210

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0210Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0210Add 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
80425-0210-1	80425021001	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0210-1)Marketed from Nov 4, 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 ERSuffix: ER
Generic name (nonproprietary): diclofenac sodium
Active ingredients: Diclofenac sodium — 100 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075492
Marketing start: Nov 4, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 80425-0210_2a99b834-0c9e-6f97-e063-6394a90a8407SPL ID 2a99b834-0c9e-6f97-e063-6394a90a8407SPL set ID ecaa39b8-067c-80d7-e053-2a95a90a7354RxCUI 855657UNII QTG126297Q
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

N480425021001 followed by a unit qualifier and the quantity

Package 80425-0210-01. 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 Dec 31, 2024. 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 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 075492

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

FDA NDC Directory listings under ANDA 075492
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-4172
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	63187-994
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-2223
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Oceanside Pharmaceuticals	68682-103
Diclofenac Sodium	Diclofenac sodium 100 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-0648