Prescription drug · ANDA
Etodolac NDC 63629-3641
Etodolac 200 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-3641-1 | 63629364101 | 60 CAPSULE in 1 BOTTLE (63629-3641-1)Marketed from May 15, 2017 | |
| 63629-3641-2 | 63629364102 | 90 CAPSULE in 1 BOTTLE (63629-3641-2)Marketed from Dec 22, 2021 | |
| 63629-3641-3 | 63629364103 | 18 CAPSULE in 1 BOTTLE (63629-3641-3)Marketed from Dec 22, 2021 |
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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 63629-3641_36d35f56-5910-4774-8dab-8faca4101c5dSPL ID 36d35f56-5910-4774-8dab-8faca4101c5dSPL set ID e7a81661-28a2-40d7-8c90-786629c81e36RxCUI 197684UNII 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
N463629364101followed by a unit qualifier and the quantityPackage 63629-3641-01. 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.
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 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1756 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1757 |
| Etodolac | Etodolac 300 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-2132 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-743 |
| Etodolac | Etodolac 200 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 62559-250 |
| 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 |