Prescription drug · ANDA
Etodolac NDC 51672-4053
Etodolac 600 mg/1 · Tablet, Extended release · Oral · TaSun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4053-1 | 51672405301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-1)Marketed from Mar 13, 2003 | |
| 51672-4053-2 | 51672405302 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-2)Marketed from Mar 13, 2003 | |
| 51672-4053-3 | 51672405303 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3)Marketed from Mar 13, 2003 | |
| 51672-4053-4 | 51672405304 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-4)Marketed from Mar 13, 2003 | |
| 51672-4053-6 | 51672405306 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-6)Marketed from Mar 13, 2003 | |
| 51672-4053-9 | 51672405309 | 10 BLISTER PACK in 1 CARTON (51672-4053-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed 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
- Generic name (nonproprietary)
- etodolac
- Active ingredients
- Etodolac — 600 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- 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 51672-4053_569a0d2d-5081-3588-e063-6394a90ad5a7SPL ID 569a0d2d-5081-3588-e063-6394a90ad5a7SPL set ID 2c5b44b4-78d5-43b2-827d-d2763b6672b3RxCUI 310245, 310247, 359500UNII 2M36281008UPC 0351672405144, 0351672405342
- 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
N451672405301followed by a unit qualifier and the quantityPackage 51672-4053-01. 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.
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 ERetodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0181 |
| 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 | 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 500 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-498 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-497 |
| Etodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | NORTHSTAR RX LLC | 16714-499 |
| Etodolac ERetodolac | Etodolac 600 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0126 |