NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7315Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7315Add 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
68788-7315-16878873150168788731501100 TABLET, FILM COATED in 1 BOTTLE (68788-7315-1)Marketed from Jan 2, 2019
68788-7315-2687887315026878873150220 TABLET, FILM COATED in 1 BOTTLE (68788-7315-2)Marketed from Jan 2, 2019
68788-7315-3687887315036878873150330 TABLET, FILM COATED in 1 BOTTLE (68788-7315-3)Marketed from Jan 2, 2019
68788-7315-6687887315066878873150660 TABLET, FILM COATED in 1 BOTTLE (68788-7315-6)Marketed from Jan 2, 2019
68788-7315-9687887315096878873150990 TABLET, FILM COATED in 1 BOTTLE (68788-7315-9)Marketed from Jan 2, 2019

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 208834
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 68788-7315_dc20bec2-e885-442a-93bb-2de09faa44c9SPL ID dc20bec2-e885-442a-93bb-2de09faa44c9SPL set ID 55ae2e78-d803-496b-b66d-af1140312785RxCUI 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

N468788731501 followed by a unit qualifier and the quantity

Package 68788-7315-01. 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 Error! Hyperlink reference not valid. ). Etodolac 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 68788-7315

What is NDC 68788-7315?
68788-7315 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 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 coatedOralAmneal Pharmaceuticals NY LLC69238-1342
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1343
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralDoc Rx69306-020
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0982
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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