What is NDC 80425-0381?

80425-0381 is the product NDC for Etodolac, Etodolac 600 mg/1 tablet, film coated, 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.

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 Etodolac?

100 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Etodolac NDC 80425-0381 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0381Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0381Add 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
80425-0381-1	8042503810180425038101	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0381-1)Marketed from Apr 10, 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): Etodolac
Generic name (nonproprietary): etodolac
Active ingredients: Etodolac — 600 mg/1
Dosage form: Tablet, Film coated, 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 091134
Marketing start: Apr 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 80425-0381_15d6ab3c-a8ab-953b-e063-6394a90a9849SPL ID 15d6ab3c-a8ab-953b-e063-6394a90a9849SPL set ID 15d6bc8e-1e25-6676-e063-6294a90a0035RxCUI 310247UNII 2M36281008
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

N480425038101 followed by a unit qualifier and the quantity

Package 80425-0381-01. 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 Apr 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets are indicated: * For relief of signs and symptoms of juvenile arthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of osteoarthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0381

What is NDC 80425-0381?: 80425-0381 is the product NDC for Etodolac, Etodolac 600 mg/1 tablet, film coated, 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?: Etodolac.
What is the active ingredient?: Etodolac.
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 Etodolac?: 100 other product NDCs are listed under this name. See all Etodolac 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 Etodolac NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-461	59651-0461-01
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-462	59651-0462-01
etodolac	Etodolac 400 mg/1	TabletOral	Ipca Laboratories Limited	83980-029	83980-0029-0183980-0029-1083980-0029-13
etodolac	Etodolac 500 mg/1	TabletOral	Ipca Laboratories Limited	83980-030	83980-0030-0183980-0030-0583980-0030-13
etodolac	Etodolac 300 mg/1	CapsuleOral	A-S Medication Solutions	50090-8037	50090-8037-01
etodolac	Etodolac 200 mg/1	CapsuleOral	Ipca Laboratories Limited	83980-031	83980-0031-0183980-0031-0583980-0031-13
etodolac	Etodolac 300 mg/1	CapsuleOral	Ipca Laboratories Limited	83980-032	83980-0032-0183980-0032-0583980-0032-13
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4542	70518-4542-00
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0551	80425-0551-01
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8846	68788-8846-0168788-8846-0268788-8846-03+2 more

All 101 Etodolac NDCs

Other NDCs under ANDA 091134

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

FDA NDC Directory listings under ANDA 091134
Product	Strength	Form · route	Labeler	Product NDC
Etodolac	Etodolac 500 mg/1	Tablet, Film coated, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-298
Etodolac	Etodolac 400 mg/1	Tablet, Film coated, Extended releaseOral	Proficient Rx LP	63187-374
Etodolac	Etodolac 600 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	63629-8598
Etodolac	Etodolac 400 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	65841-777
Etodolac	Etodolac 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	65841-778
Etodolac	Etodolac 600 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Lifesciences Limited	65841-779
Etodolac	Etodolac 400 mg/1	Tablet, Film coated, Extended releaseOral	NuCare Pharmaceuticals, Inc.	68071-3731
Etodolac	Etodolac 400 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-271
Etodolac	Etodolac 500 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-272
Etodolac	Etodolac 600 mg/1	Tablet, Film coated, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	68382-273