What is NDC 71610-804?

71610-804 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-804 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-804Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0804Add 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
71610-804-30	7161008043071610080430	30 TABLET, FILM COATED in 1 BOTTLE (71610-804-30)Marketed from Mar 15, 2024
71610-804-53	7161008045371610080453	60 TABLET, FILM COATED in 1 BOTTLE (71610-804-53)Marketed from Mar 15, 2024
71610-804-60	7161008046071610080460	90 TABLET, FILM COATED in 1 BOTTLE (71610-804-60)Marketed from Mar 15, 2024
71610-804-80	7161008048071610080480	180 TABLET, FILM COATED in 1 BOTTLE (71610-804-80)Marketed from Mar 15, 2024

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): Etodolac
Generic name (nonproprietary): etodolac
Active ingredients: Etodolac — 400 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076004
Marketing start: May 1, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers: Product ID 71610-804_141bf837-5a1f-da26-e063-6294a90a20bcSPL ID 141bf837-5a1f-da26-e063-6294a90a20bcSPL set ID 141be3f6-198d-ce46-e063-6294a90a7993RxCUI 197686UNII 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

N471610080430 followed by a unit qualifier and the quantity

Package 71610-0804-30. 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 Mar 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets, USP 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 71610-804

What is NDC 71610-804?: 71610-804 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 076004

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

FDA NDC Directory listings under ANDA 076004
Product	Strength	Form · route	Labeler	Product NDC
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-578
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-671
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-856
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	Medsource Pharmaceuticals	45865-206
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1790
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-0041
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-0102
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	St. Marys Medical Park Pharmacy	60760-552
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-736
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8805
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8846
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3845
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4542
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-467
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0126
Etodolac	Etodolac 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0399
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-538
Etodolac	Etodolac 400 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0190