NDC codes

FDA NDC Directory
Product NDC (as listed)16714-497Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0497Add 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
16714-497-011671404970160 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01)Marketed from Aug 15, 2016
16714-497-0216714049702100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02)Marketed from Aug 15, 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
Etodolac — 400 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
NORTHSTAR RX LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076174
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 16714-497_38568f45-b334-0e6f-e063-6294a90a178aSPL ID 38568f45-b334-0e6f-e063-6294a90a178aSPL set ID 107ea9d7-80a9-41a4-b61e-168370127319RxCUI 310245, 310247, 359500UNII 2M36281008UPC 0316714497020, 0316714498027

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

N416714049701 followed by a unit qualifier and the quantity

Package 16714-0497-01. 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 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)

About NDC 16714-497

What is NDC 16714-497?
16714-497 is the product NDC for Etodolac, Etodolac 400 mg/1 tablet, extended release, listed with the FDA by NORTHSTAR RX LLC. It has 2 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?
NORTHSTAR RX LLC, NDC labeler code 16714. 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 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 300 mg/1CapsuleOralA-S Medication Solutions50090-803750090-8037-01
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 076174

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

FDA NDC Directory listings under ANDA 076174
ProductStrengthForm · routeLabelerProduct NDC
EtodolacEtodolac 500 mg/1Tablet, Extended releaseOralNORTHSTAR RX LLC16714-498
Etodolac ERetodolacEtodolac 600 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0181
EtodolacEtodolac 400 mg/1Tablet, Extended releaseOralTaSun Pharmaceutical Industries, Inc.51672-4051
EtodolacEtodolac 500 mg/1Tablet, Extended releaseOralTaSun Pharmaceutical Industries, Inc.51672-4052
EtodolacEtodolac 600 mg/1Tablet, Extended releaseOralTaSun Pharmaceutical Industries, Inc.51672-4053
EtodolacEtodolac 600 mg/1Tablet, Extended releaseOralNORTHSTAR RX LLC16714-499
EtodolacEtodolac 500 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-314
EtodolacEtodolac 400 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-313
EtodolacEtodolac 400 mg/1Tablet, Extended releaseOralProficient Rx LP63187-793
Etodolac ERetodolacEtodolac 600 mg/1Tablet, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0126

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