NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0982Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0982Add 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
71335-0982-1713350982017133509820120 TABLET, FILM COATED in 1 BOTTLE (71335-0982-1)Marketed from Nov 9, 2018
71335-0982-2713350982027133509820214 TABLET, FILM COATED in 1 BOTTLE (71335-0982-2)Marketed from Apr 9, 2024
71335-0982-3713350982037133509820330 TABLET, FILM COATED in 1 BOTTLE (71335-0982-3)Marketed from Oct 30, 2018
71335-0982-47133509820471335098204100 TABLET, FILM COATED in 1 BOTTLE (71335-0982-4)Marketed from Apr 9, 2024
71335-0982-5713350982057133509820560 TABLET, FILM COATED in 1 BOTTLE (71335-0982-5)Marketed from Nov 28, 2018
71335-0982-6713350982067133509820690 TABLET, FILM COATED in 1 BOTTLE (71335-0982-6)Marketed from Apr 9, 2024
71335-0982-7713350982077133509820756 TABLET, FILM COATED in 1 BOTTLE (71335-0982-7)Marketed from Dec 19, 2018
71335-0982-87133509820871335098208120 TABLET, FILM COATED in 1 BOTTLE (71335-0982-8)Marketed from Apr 9, 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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208834
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71335-0982_daca716b-058d-47da-b814-0ad4865c8d7aSPL ID daca716b-058d-47da-b814-0ad4865c8d7aSPL set ID 53160db5-ba48-4cac-afbe-acd608daa0dcRxCUI 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

N471335098201 followed by a unit qualifier and the quantity

Package 71335-0982-01. 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 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 71335-0982

What is NDC 71335-0982?
71335-0982 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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 208834

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

FDA NDC Directory listings under ANDA 208834
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3963
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3974
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4053
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-423
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-735
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7315
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1342
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1343
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralDoc Rx69306-020
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1230
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-794
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0140

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