What is NDC 76420-029?

76420-029 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Asclemed USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Indomethacin NDC 76420-029 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-029Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0029Add 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
76420-029-01	7642000290176420002901	1 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-01)Marketed from Feb 11, 2020
76420-029-02	7642000290276420002902	2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-02)Marketed from Feb 11, 2020
76420-029-07	7642000290776420002907	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-07)Marketed from Feb 11, 2020
76420-029-14	7642000291476420002914	14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-029-14)Marketed from Feb 11, 2020

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: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201807
Marketing start: Jul 24, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 76420-029_ead13cff-b9d2-cdc1-e053-2a95a90adf09SPL ID ead13cff-b9d2-cdc1-e053-2a95a90adf09SPL set ID dfdcdb27-07a0-47e6-b8da-d9c99045a066RxCUI 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

N476420002901 followed by a unit qualifier and the quantity

Package 76420-0029-01. 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 Oct 12, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-029

What is NDC 76420-029?: 76420-029 is the product NDC for Indomethacin, Indomethacin 75 mg/1 capsule, extended release, listed with the FDA by Asclemed USA, Inc.. It has 4 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?: Asclemed USA, Inc., NDC labeler code 76420. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Indomethacin	Indomethacin 50 mg/1	CapsuleOral	Coupler LLC	67046-0416	67046-0416-03
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	NorthStar RxLLC	72603-281	72603-0281-30
Indomethacin	Indomethacin 50 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-4055	68788-4055-03
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	Camber Pharmaceuticals, Inc.	31722-051	31722-0051-31
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	Amneal Pharmaceuticals NY LLC	69238-2086	69238-2086-03
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	Hikma Pharmaceuticals USA Inc.	0054-1950	00054-1950-30
Indomethacin	Indomethacin 50 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-916	60760-0916-2160760-0916-30
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	Zydus Pharmaceuticals USA Inc.	70710-1958	70710-1958-07
Indomethacin	Indomethacin 25 mg/5mL	SuspensionOral	ANI Pharmaceuticals, Inc.	70954-637	70954-0637-10
Indomethacin	Indomethacin 50 mg/1	SuppositoryRectal	Zydus Pharmaceuticals USA Inc.	70710-1852	70710-1852-07

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
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	Sportpharm LLC	85766-034
Indomethacin ERindomethacin	Indomethacin 75 mg/1	Capsule, Extended releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0271