What is NDC 62135-456?

62135-456 is the product NDC for Diflunisal, Diflunisal 500 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diflunisal?

4 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diflunisal NDC 62135-456 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-456Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0456Add 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
62135-456-60	6213504566062135045660	60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)Marketed from Jan 31, 2023

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): Diflunisal
Generic name (nonproprietary): diflunisal
Active ingredients: Diflunisal — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Chartwell RX, LLCNDC labeler code 62135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202845
Marketing start: Mar 8, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 62135-456_242086f3-3373-fac8-e063-6394a90a82abSPL ID 242086f3-3373-fac8-e063-6394a90a82abSPL set ID 2043bab8-87c9-45ce-88c7-383f0d4c4b64RxCUI 197603UNII 7C546U4DENUPC 0362135456603
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

N462135045660 followed by a unit qualifier and the quantity

Package 62135-0456-60. 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 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62135-456

What is NDC 62135-456?: 62135-456 is the product NDC for Diflunisal, Diflunisal 500 mg/1 tablet, film coated, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diflunisal.
What is the active ingredient?: Diflunisal.
Who is the labeler?: Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diflunisal?: 4 other product NDCs are listed under this name. See all Diflunisal NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diflunisal NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diflunisal	Diflunisal 500 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-9222	00093-9222-0100093-9222-0500093-9222-06
Diflunisal	Diflunisal 500 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-530	68382-0530-0168382-0530-0568382-0530-06+4 more
Diflunisal	Diflunisal 500 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1083	70771-1083-0070771-1083-0170771-1083-03+4 more
diflunisal	Diflunisal 500 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-673	14539-0673-0114539-0673-0514539-0673-06

Other NDCs under ANDA 202845

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

FDA NDC Directory listings under ANDA 202845
Product	Strength	Form · route	Labeler	Product NDC
diflunisal	Diflunisal 500 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-673
Dolobiddiflunisal	Diflunisal 250 mg/1	Tablet, Film coatedOral	INA Pharmaceutics Inc	74157-009
Dolobiddiflunisal	Diflunisal 375 mg/1	Tablet, Film coatedOral	INA Pharmaceutics Inc	74157-101