NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0551Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0551Add 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
80425-0551-1804250551018042505510160 TABLET, FILM COATED in 1 BOTTLE (80425-0551-1)Marketed from Aug 29, 2025

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 — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075074
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 80425-0551_3d87cc75-7a10-46a2-e063-6294a90a6d49SPL ID 3d87cc75-7a10-46a2-e063-6294a90a6d49SPL set ID 3d865ff0-fc45-1e95-e063-6294a90a8e18RxCUI 197686UNII 2M36281008

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

N480425055101 followed by a unit qualifier and the quantity

Package 80425-0551-01. 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)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets are indicated: For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis For the management of acute pain

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0551

What is NDC 80425-0551?
80425-0551 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Advanced Rx 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 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-46159651-0461-01
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-46259651-0462-01
etodolacEtodolac 400 mg/1TabletOralIpca Laboratories Limited83980-02983980-0029-0183980-0029-1083980-0029-13
etodolacEtodolac 500 mg/1TabletOralIpca Laboratories Limited83980-03083980-0030-0183980-0030-0583980-0030-13
etodolacEtodolac 300 mg/1CapsuleOralA-S Medication Solutions50090-803750090-8037-01
etodolacEtodolac 200 mg/1CapsuleOralIpca Laboratories Limited83980-03183980-0031-0183980-0031-0583980-0031-13
etodolacEtodolac 300 mg/1CapsuleOralIpca Laboratories Limited83980-03283980-0032-0183980-0032-0583980-0032-13
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-454270518-4542-00
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-884668788-8846-0168788-8846-0268788-8846-03+2 more
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-429170518-4291-00

All 101 Etodolac NDCs

Other NDCs under ANDA 075074

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

FDA NDC Directory listings under ANDA 075074
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1489
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.51672-4018
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.51672-4036
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-311
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-312
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8673
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4291
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1958
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-779
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-795
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-816
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-859

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