NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8673Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8673Add 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
68788-8673-168788867301100 TABLET, FILM COATED in 1 BOTTLE (68788-8673-1)Marketed from May 22, 2024
68788-8673-26878886730220 TABLET, FILM COATED in 1 BOTTLE (68788-8673-2)Marketed from May 22, 2024
68788-8673-36878886730330 TABLET, FILM COATED in 1 BOTTLE (68788-8673-3)Marketed from May 22, 2024
68788-8673-66878886730660 TABLET, FILM COATED in 1 BOTTLE (68788-8673-6)Marketed from May 22, 2024
68788-8673-96878886730990 TABLET, FILM COATED in 1 BOTTLE (68788-8673-9)Marketed from May 22, 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 — 400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-8673_57f3f31f-ad26-40e2-a5aa-167b4e8bc781SPL ID 57f3f31f-ad26-40e2-a5aa-167b4e8bc781SPL set ID 117b3005-a8ec-4f76-824c-95ec42dc87a1RxCUI 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

N468788867301 followed by a unit qualifier and the quantity

Package 68788-8673-01. 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: o Osteoarthritis o 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 68788-8673

What is NDC 68788-8673?
68788-8673 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 300 mg/1CapsuleOralA-S Medication Solutions50090-803750090-8037-01
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-454270518-4542-00
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-055180425-0551-01
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-884668788-8846-0168788-8846-0268788-8846-03+2 more

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 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1958
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1489
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 coatedOralAdvanced Rx of Tennessee, LLC80425-0551
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-816
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4291
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 coatedOralAphena Pharma Solutions - Tennessee, LLC71610-859
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.51672-4018
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.51672-4036

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