NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4053Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4053Add 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
50090-4053-05009040530020 TABLET, FILM COATED in 1 BOTTLE (50090-4053-0)Marketed from Jan 14, 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
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 50090-4053_178b670c-c87c-44ce-b28c-ee83aecfcf02SPL ID 178b670c-c87c-44ce-b28c-ee83aecfcf02SPL set ID 336d5331-4d60-42e2-8cfc-aad57c01eda0RxCUI 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

N450090405300 followed by a unit qualifier and the quantity

Package 50090-4053-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 coatedOralAphena Pharma Solutions - Tennessee, LLC71610-794
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0982
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1342
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7315
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals NY LLC69238-1343
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-735
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1230
EtodolacEtodolac 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3974
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3963
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-423
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0140
EtodolacEtodolac 400 mg/1Tablet, Film coatedOralDoc Rx69306-020

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