What is NDC 80425-0271?

80425-0271 is the product NDC for Indomethacin ER (indomethacin), Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Indomethacin ER (Indomethacin).

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 ER?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Indomethacin ER NDC 80425-0271 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0271Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0271Add 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	Copy
80425-0271-1	8042502710180425027101	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0271-1)Marketed from Feb 17, 2023

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 ERSuffix: ER
Generic name (nonproprietary): indomethacin
Active ingredients: Indomethacin — 75 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201807
Marketing start: Feb 17, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0271_2a9bad62-b300-697c-e063-6294a90aa395SPL ID 2a9bad62-b300-697c-e063-6294a90aa395SPL set ID f4e8a719-ef9c-a2ef-e053-2995a90ad788RxCUI 310992UNII XXE1CET956
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

N480425027101 followed by a unit qualifier and the quantity

Package 80425-0271-01. 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 Dec 31, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin extended-release capsules have been found effective in active stages of the following: 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. Moderate to severe ankylosing spondylitis. 3. Moderate to severe osteoarthritis. 4. Acute painful shoulder (bursitis and/or tendinitis). Indomethacin extended-release capsules, USP are not recommended fo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0271

What is NDC 80425-0271?: 80425-0271 is the product NDC for Indomethacin ER (indomethacin), Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Indomethacin ER (Indomethacin).
What is the active ingredient?: Indomethacin.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 ER?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-565
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Northwind Health Company, LLC	51655-443
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	63629-1915
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-0515
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Proficient Rx LP	71205-822
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-0756
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	72162-1302
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Asclemed USA, Inc.	76420-029
Indomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Sportpharm LLC	85766-034

Indomethacin ER (Indomethacin) NDC 80425-0271