Diclofenac Potassium NDC 63629-4108

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-4108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-4108Add 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
63629-4108-1	63629410801	20 TABLET, FILM COATED in 1 BOTTLE (63629-4108-1)Marketed from Dec 2, 2009
63629-4108-2	63629410802	90 TABLET, FILM COATED in 1 BOTTLE (63629-4108-2)Marketed from Apr 20, 2010
63629-4108-3	63629410803	30 TABLET, FILM COATED in 1 BOTTLE (63629-4108-3)Marketed from May 25, 2010
63629-4108-4	63629410804	60 TABLET, FILM COATED in 1 BOTTLE (63629-4108-4)Marketed from Jan 6, 2011
63629-4108-5	63629410805	45 TABLET, FILM COATED in 1 BOTTLE (63629-4108-5)Marketed from Dec 22, 2021
63629-4108-6	63629410806	58 TABLET, FILM COATED in 1 BOTTLE (63629-4108-6)Marketed from Dec 22, 2021
63629-4108-7	63629410807	18 TABLET, FILM COATED in 1 BOTTLE (63629-4108-7)Marketed from Dec 22, 2021
63629-4108-8	63629410808	120 TABLET, FILM COATED in 1 BOTTLE (63629-4108-8)Marketed from Dec 22, 2021

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
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075219
Marketing start: Aug 11, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 63629-4108_37d9b7c1-4bf8-44ed-8d48-bd1ee6efd72cSPL ID 37d9b7c1-4bf8-44ed-8d48-bd1ee6efd72cSPL set ID 717341fc-e067-0005-215c-053f6d12e0d1RxCUI 855942UNII L4D5UA6CB4
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

N463629410801 followed by a unit qualifier and the quantity

Package 63629-4108-01. 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 Oct 3, 2023. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-0948
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-848
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8411
Diclofenac Potassium	Diclofenac potassium 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	66267-070