Prescription drug · ANDA
Sulindac NDC 42806-011
Sulindac 200 mg/1 · Tablet · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-011-01 | 4280600110142806001101 | 100 TABLET in 1 BOTTLE (42806-011-01)Marketed from Jan 25, 2010 | |
| 42806-011-05 | 4280600110542806001105 | 500 TABLET in 1 BOTTLE (42806-011-05)Marketed from Jan 25, 2010 | |
| 42806-011-10 | 4280600111042806001110 | 1000 TABLET in 1 BOTTLE (42806-011-10)Marketed from Jan 25, 2010 |
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)
- Sulindac
- Generic name (nonproprietary)
- sulindac
- Active ingredients
- Sulindac — 200 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072711
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 42806-011_fb793a0a-affa-4f9a-a5b4-aa1c84aa475eSPL ID fb793a0a-affa-4f9a-a5b4-aa1c84aa475eSPL set ID 96c73bd2-4577-487d-a642-bd8f91e94c3aRxCUI 198238, 198239UNII 184SNS8VUHUPC 0342806018057, 0342806011010
- 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
N442806001101followed by a unit qualifier and the quantityPackage 42806-0011-01. 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 sulindac and other treatment options before deciding to use sulindac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis** 3. Ankylosing spondylitis 4. Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) 5. Acute gouty arthritis **The safety and effectiveness of sulindac tablets USP have not been established in rheumatoid arthritis patients who are designated in the American Rh…
Excerpt only. Read the full label for complete information.
About NDC 42806-011
- What is NDC 42806-011?
- 42806-011 is the product NDC for Sulindac, Sulindac 200 mg/1 tablet, listed with the FDA by Epic Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulindac.
- What is the active ingredient?
- Sulindac.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sulindac?
- 12 other product NDCs are listed under this name. See all Sulindac NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sulindac products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sulindac | Sulindac 150 mg/1 | TabletOral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-770 | 24658-0770-0124658-0770-05 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-771 | 24658-0771-0124658-0771-05 |
| Sulindac | Sulindac 150 mg/1 | TabletOral | Epic Pharma, LLC | 42806-018 | 42806-0018-0142806-0018-0542806-0018-10 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-0529 | 50090-0529-04 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | Proficient Rx LP | 71205-648 | 71205-0648-3071205-0648-6071205-0648-90 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-2093 | 50090-2093-04 |
| Sulindac | Sulindac 150 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-478 | 53489-0478-0153489-0478-0253489-0478-03+3 more |
| Sulindac | Sulindac 200 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-479 | 53489-0479-0153489-0479-0253489-0479-03+3 more |
| Sulindac | Sulindac 150 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-373 | 72789-0373-0172789-0373-82 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-374 | 72789-0374-0172789-0374-82 |
Other NDCs under ANDA 072711
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 |
|---|---|---|---|---|
| Sulindac | Sulindac 200 mg/1 | TabletOral | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-771 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | A-S Medication Solutions | 50090-0529 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | Proficient Rx LP | 71205-648 |