Prescription drug · ANDA
Etodolac NDC 62559-250
Etodolac 200 mg/1 · Capsule · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-250-01 | 6255902500162559025001 | 100 CAPSULE in 1 BOTTLE (62559-250-01)Marketed from Mar 9, 2015 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075126
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 62559-250_b45612f5-5724-43e1-a1e4-c9f9c0ce5c5bSPL ID b45612f5-5724-43e1-a1e4-c9f9c0ce5c5bSPL set ID 420c7b62-3bea-4d6b-82e0-ab1c176c7f1eRxCUI 197684, 197685UNII 2M36281008UPC 0362559251013, 0362559250016
- 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
N462559025001followed by a unit qualifier and the quantityPackage 62559-0250-01. 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 other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis • For the management of acute pain
Excerpt only. Read the full label for complete information.
About NDC 62559-250
- What is NDC 62559-250?
- 62559-250 is the product NDC for Etodolac, Etodolac 200 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. 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.
Related NDCs: other Etodolac 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 | Etodolac 400 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-461 | 59651-0461-01 |
| Etodolac | Etodolac 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-462 | 59651-0462-01 |
| etodolac | Etodolac 400 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-029 | 83980-0029-0183980-0029-1083980-0029-13 |
| etodolac | Etodolac 500 mg/1 | TabletOral | Ipca Laboratories Limited | 83980-030 | 83980-0030-0183980-0030-0583980-0030-13 |
| etodolac | Etodolac 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-8037 | 50090-8037-01 |
| etodolac | Etodolac 200 mg/1 | CapsuleOral | Ipca Laboratories Limited | 83980-031 | 83980-0031-0183980-0031-0583980-0031-13 |
| etodolac | Etodolac 300 mg/1 | CapsuleOral | Ipca Laboratories Limited | 83980-032 | 83980-0032-0183980-0032-0583980-0032-13 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4542 | 70518-4542-00 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0551 | 80425-0551-01 |
| Etodolac | Etodolac 400 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8846 | 68788-8846-0168788-8846-0268788-8846-03+2 more |
Other NDCs under ANDA 075126
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 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2132 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-251 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1935 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1936 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-3641 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-743 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1756 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1757 |