NDC codes

FDA NDC Directory
Product NDC (as listed)31722-565Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0565Add 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
31722-565-013172205650131722056501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-01)Marketed from Jul 24, 2015
31722-565-053172205650531722056505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-05)Marketed from Jul 24, 2015
31722-565-1031722056510317220565101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-10)Marketed from Jul 24, 2015
31722-565-30317220565303172205653030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-30)Marketed from Jul 24, 2015
31722-565-60317220565603172205656060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-565-60)Marketed from Jul 24, 2015

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
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201807
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 31722-565_349e2ce2-f399-926c-e063-6294a90a9185SPL ID 349e2ce2-f399-926c-e063-6294a90a9185SPL set ID 12f62bae-5fc0-4f8d-a8b4-446524bd53d1RxCUI 310992UNII XXE1CET956UPC 0331722565011

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

N431722056501 followed by a unit qualifier and the quantity

Package 31722-0565-01. 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 . 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)

About NDC 31722-565

What is NDC 31722-565?
31722-565 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Indomethacin.
What is the active ingredient?
Indomethacin.
Who is the labeler?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Indomethacin?
79 other product NDCs are listed under this name. See all Indomethacin 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 Indomethacin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IndomethacinIndomethacin 50 mg/1CapsuleOralCoupler LLC67046-041667046-0416-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalNorthStar RxLLC72603-28172603-0281-30
IndomethacinIndomethacin 50 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-405568788-4055-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalCamber Pharmaceuticals, Inc.31722-05131722-0051-31
IndomethacinIndomethacin 50 mg/1SuppositoryRectalAmneal Pharmaceuticals NY LLC69238-208669238-2086-03
IndomethacinIndomethacin 50 mg/1SuppositoryRectalHikma Pharmaceuticals USA Inc.0054-195000054-1950-30
IndomethacinIndomethacin 50 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-91660760-0916-2160760-0916-30
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Pharmaceuticals USA Inc.70710-195870710-1958-07
IndomethacinIndomethacin 25 mg/5mLSuspensionOralANI Pharmaceuticals, Inc.70954-63770954-0637-10
IndomethacinIndomethacin 50 mg/1SuppositoryRectalZydus Pharmaceuticals USA Inc.70710-185270710-1852-07

All 80 Indomethacin NDCs

Other NDCs under ANDA 201807

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

FDA NDC Directory listings under ANDA 201807
ProductStrengthForm · routeLabelerProduct NDC
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralNorthwind Health Company, LLC51655-443
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack63629-1915
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-0515
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralProficient Rx LP71205-822
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-0756
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack72162-1302
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-029
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralSportpharm LLC85766-034
Indomethacin ERindomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0271

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in