Prescription drug · ANDA
Etodolac ER (Etodolac) NDC 80425-0126
Etodolac 600 mg/1 · Tablet, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0126-1 | 8042501260180425012601 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0126-1)Marketed from Mar 13, 2003 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- etodolac
- Active ingredients
- Etodolac — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0126_2a99bd40-3c4c-3207-e063-6294a90a4faaSPL ID 2a99bd40-3c4c-3207-e063-6294a90a4faaSPL set ID baebdfb2-17f6-9081-e053-2a95a90ab331RxCUI 310247UNII 2M36281008
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N480425012601followed by a unit qualifier and the quantityPackage 80425-0126-01. 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 Section 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.
About NDC 80425-0126
- What is NDC 80425-0126?
- 80425-0126 is the product NDC for Etodolac ER (etodolac), Etodolac 600 mg/1 tablet, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etodolac ER (Etodolac).
- What is the active ingredient?
- Etodolac.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 ER?
- 1 other product NDC are listed under this name. See all Etodolac ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Etodolac ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Etodolac ERetodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0181 | 80425-0181-01 |
Other NDCs under ANDA 076174
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Etodolac | Etodolac 400 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-497 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-498 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-499 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Extended releaseOral | TaSun Pharmaceutical Industries, Inc. | 51672-4051 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Extended releaseOral | TaSun Pharmaceutical Industries, Inc. | 51672-4052 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | TaSun Pharmaceutical Industries, Inc. | 51672-4053 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-313 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 60429-314 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-793 |
| Etodolac ERetodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0181 |