NDC codes

FDA NDC Directory
Product NDC (as listed)42799-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0111Add 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
42799-111-0142799011101100 TABLET, FILM COATED in 1 BOTTLE (42799-111-01)Marketed from Dec 7, 2018

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
Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209888
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 42799-111_462de1d4-dc95-527d-e063-6394a90ad55aSPL ID 462de1d4-dc95-527d-e063-6394a90ad55aSPL set ID bf1afcd5-e1da-4874-981f-f252cb0b32c2RxCUI 197686, 199390UNII 2M36281008UPC 0342799111018, 0342799112015

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

N442799011101 followed by a unit qualifier and the quantity

Package 42799-0111-01. 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 & USAGE Carefully consider the potential benefits and risks of Etodolac Tablets and other treatment options before deciding to use Etodolac Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac 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 42799-111

What is NDC 42799-111?
42799-111 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Edenbridge Pharmaceuticals 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?
Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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 500 mg/1TabletOralIpca Laboratories Limited83980-03083980-0030-0183980-0030-0583980-0030-13
etodolacEtodolac 400 mg/1TabletOralIpca Laboratories Limited83980-02983980-0029-0183980-0029-1083980-0029-13
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 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 209888

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

FDA NDC Directory listings under ANDA 209888
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralEdenbridge Pharmaceuticals LLC.42799-112
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-911
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-910

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