NDC codes

FDA NDC Directory
Product NDC (as listed)63187-736Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0736Add 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
63187-736-206318707362020 TABLET, FILM COATED in 1 BOTTLE (63187-736-20)Marketed from Aug 1, 2016
63187-736-306318707363030 TABLET, FILM COATED in 1 BOTTLE (63187-736-30)Marketed from Aug 1, 2016
63187-736-606318707366060 TABLET, FILM COATED in 1 BOTTLE (63187-736-60)Marketed from Aug 1, 2016
63187-736-906318707369090 TABLET, FILM COATED in 1 BOTTLE (63187-736-90)Marketed from Aug 1, 2016

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
Etodolac400 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076004
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 63187-736_1df6a536-d2d9-4d3b-bc5b-91e7a26beed2SPL ID 1df6a536-d2d9-4d3b-bc5b-91e7a26beed2SPL set ID e2fef939-2f4a-46ae-8177-073f5e8f57f5RxCUI 197686UNII 2M36281008UPC 0363187736200

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

N463187073620 followed by a unit qualifier and the quantity

Package 63187-0736-20. 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 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: 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)

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
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0190
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1790
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-538
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-856
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralMedsource Pharmaceuticals45865-206
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-804
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3845
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8846
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4542
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-467
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-578
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0399
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralApotex Corp.60505-0041
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0126
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralApotex Corp.60505-0102
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-671
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralSt. Marys Medical Park Pharmacy60760-552
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8805

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