NDC codes

FDA NDC Directory
Product NDC (as listed)71205-140Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0140Add 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
71205-140-307120501403030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-30)Marketed from Oct 31, 2018
71205-140-607120501406060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-60)Marketed from Oct 31, 2018
71205-140-907120501409090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-140-90)Marketed from Oct 31, 2018

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, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075665
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 71205-140_524617eb-4404-4d2e-8d0c-478294af8a27SPL ID 524617eb-4404-4d2e-8d0c-478294af8a27SPL set ID 5a040d8e-8d0c-442f-b4e5-161aa7ccbe9aRxCUI 310245UNII 2M36281008UPC 0371205140304

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

N471205014030 followed by a unit qualifier and the quantity

Package 71205-0140-30. 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 extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac extended-release tablets are indicated: * For relief of signs and symptoms of juvenile arthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of osteoarthritis

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075665

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

FDA NDC Directory listings under ANDA 075665
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 500 mg/1Tablet, Film coated, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-7172
EtodolacEtodolac 600 mg/1Tablet, Film coated, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-1118
EtodolacEtodolac 400 mg/1Tablet, Film coated, Extended releaseOralTeva Pharmaceuticals USA, Inc.0093-1122

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in