Sulindac NDC 53489-478

NDC codes

FDA NDC Directory

Product NDC (as listed)53489-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53489-0478Add 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
53489-478-01	53489047801	100 TABLET in 1 BOTTLE, PLASTIC (53489-478-01)Marketed from Sep 4, 2009
53489-478-02	53489047802	50 TABLET in 1 BOTTLE, PLASTIC (53489-478-02)Marketed from Sep 4, 2009
53489-478-03	53489047803	250 TABLET in 1 BOTTLE, PLASTIC (53489-478-03)Marketed from Sep 4, 2009
53489-478-05	53489047805	500 TABLET in 1 BOTTLE, PLASTIC (53489-478-05)Marketed from Sep 4, 2009
53489-478-06	53489047806	60 TABLET in 1 BOTTLE, PLASTIC (53489-478-06)Marketed from Sep 4, 2009
53489-478-10	53489047810	1000 TABLET in 1 BOTTLE, PLASTIC (53489-478-10)Marketed from Sep 4, 2009

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): Sulindac
Generic name (nonproprietary): sulindac
Active ingredients: Sulindac — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072050
Marketing start: Sep 4, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 53489-478_2524fd49-5789-e388-e063-6394a90a2c9bSPL ID 2524fd49-5789-e388-e063-6394a90a2c9bSPL set ID a47e4259-d44b-4b7b-b517-841cb6840982RxCUI 198238, 198239UNII 184SNS8VUHUPC 0353489479011, 0353489478014
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

N453489047801 followed by a unit qualifier and the quantity

Package 53489-0478-01. 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 23, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis* Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072050

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

FDA NDC Directory listings under ANDA 072050
Product	Strength	Form · route	Labeler	Product NDC
Sulindac	Sulindac 150 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-373