NDC codes

FDA NDC Directory
Product NDC (as listed)55289-930Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55289-0930Add 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 NDC11-digit (billing)PackageCopy
55289-930-105528909301010 TABLET in 1 BOTTLE, PLASTIC (55289-930-10)Marketed from Jul 12, 2010
55289-930-205528909302020 TABLET in 1 BOTTLE, PLASTIC (55289-930-20)Marketed from Jul 12, 2010
55289-930-305528909303030 TABLET in 1 BOTTLE, PLASTIC (55289-930-30)Marketed from Jul 12, 2010

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 — 200 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071795
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 55289-930_30ca698c-7fb2-9fa7-e063-6294a90abd86SPL ID 30ca698c-7fb2-9fa7-e063-6294a90abd86SPL set ID 68d4eeed-2501-494b-b979-502720de86c0RxCUI 198239UNII 184SNS8VUHUPC 0355289930105

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

N455289093010 followed by a unit qualifier and the quantity

Package 55289-0930-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets, USP 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 **The safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the American Rheumatism Asso…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 071795

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

FDA NDC Directory listings under ANDA 071795
ProductStrengthForm · routeLabelerProduct NDC
SulindacSulindac 200 mg/1TabletOralActavis Pharma, Inc.0591-5660

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