NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9754Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9754Add 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
71335-9754-1713359754017133597540130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-1)Marketed from Sep 21, 2023
71335-9754-2713359754027133597540260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-2)Marketed from Apr 9, 2024
71335-9754-3713359754037133597540314 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-3)Marketed from Aug 1, 2023
71335-9754-4713359754047133597540410 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-4)Marketed from Apr 9, 2024
71335-9754-571335975405713359754057 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-5)Marketed from Apr 9, 2024
71335-9754-6713359754067133597540615 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-6)Marketed from Apr 9, 2024
71335-9754-7713359754077133597540720 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-7)Marketed from Apr 9, 2024
71335-9754-8713359754087133597540890 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-8)Marketed from Apr 9, 2024
71335-9754-97133597540971335975409100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9754-9)Marketed from Apr 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-9754_6f8b687c-33f2-4936-ac92-aceadb1a90adSPL ID 6f8b687c-33f2-4936-ac92-aceadb1a90adSPL set ID 41af7776-36bc-4820-b635-e7c69f26997eRxCUI 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

N471335975401 followed by a unit qualifier and the quantity

Package 71335-9754-01. 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 71335-9754

What is NDC 71335-9754?
71335-9754 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 9 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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 releaseOralKVK-Tech, Inc.10702-016
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralPD-Rx Pharmaceuticals, Inc.55289-469
IndomethacinIndomethacin 75 mg/1Capsule, Extended releaseOralAmerican Health Packaging68084-411

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