NDC codes

FDA NDC Directory
Product NDC (as listed)51672-4017Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-4017Add 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
51672-4017-151672401701100 CAPSULE in 1 BOTTLE (51672-4017-1)Marketed from Apr 30, 1998

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
Etodolac300 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075078
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 51672-4017_56a612ca-5035-8653-e063-6394a90acb15SPL ID 56a612ca-5035-8653-e063-6394a90acb15SPL set ID ec82b108-6a6f-4d1b-82cb-831d4ed36c80RxCUI 197684, 197685, 197686, 199390UNII 2M36281008UPC 0351672401818

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

N451672401701 followed by a unit qualifier and the quantity

Package 51672-4017-01. 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 capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and 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)

Other NDCs under ANDA 075078

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

FDA NDC Directory listings under ANDA 075078
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 200 mg/1CapsuleOralBryant Ranch Prepack71335-3119
EtodolacEtodolac 300 mg/1CapsuleOralGolden State Medical Supply, Inc.60429-244
EtodolacEtodolac 200 mg/1CapsuleOralGolden State Medical Supply, Inc.60429-243
EtodolacEtodolac 200 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4016

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