NDC codes

FDA NDC Directory
Product NDC (as listed)55289-469Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55289-0469Add 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
55289-469-105528904691010 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-469-10)Marketed from Jul 27, 2012

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)
Indomethacin
Generic name (nonproprietary)
indomethacin
Active ingredients
Indomethacin — 75 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079175
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 55289-469_34679342-bf84-f9e4-e063-6294a90aae55SPL ID 34679342-bf84-f9e4-e063-6294a90aae55SPL set ID 85014b51-1354-4d16-9995-3ee33a7155faRxCUI 310992UNII XXE1CET956

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

N455289046910 followed by a unit qualifier and the quantity

Package 55289-0469-10. 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)

Indomethacin extended-release capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079175

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

FDA NDC Directory listings under ANDA 079175
ProductStrengthForm · routeLabelerProduct NDC
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralAmerican Health Packaging68084-411
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralKVK-Tech, Inc.10702-016
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-9754

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