Prescription drug · ANDA
Sulindac NDC 72789-374
Sulindac 200 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-374-01 | 7278903740172789037401 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01)Marketed from Aug 27, 2024 | |
| 72789-374-82 | 7278903748272789037482 | 500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82)Marketed from Jan 25, 2024 |
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
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072051
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 72789-374_31f654da-06fe-9e86-e063-6294a90a3312SPL ID 31f654da-06fe-9e86-e063-6294a90a3312SPL set ID 1fffe88d-50c8-45cf-ac7c-a62b665c89a8RxCUI 198239UNII 184SNS8VUHUPC 0372789374826
- 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
N472789037401followed by a unit qualifier and the quantityPackage 72789-0374-01. 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 tablets and other treatment options before deciding to use sulindac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Sulindac tablets are indicated for acute or long-term use in the relief of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis* Ankylosing spondylitis Acute painful shoulder (Acute subacromial bursitis/supraspinatus tendinitis) Acute gouty arthritis
Excerpt only. Read the full label for complete information.
About NDC 72789-374
- What is NDC 72789-374?
- 72789-374 is the product NDC for Sulindac, Sulindac 200 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 2 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 200 mg/1 | TabletOral | Epic Pharma, LLC | 42806-011 | 42806-0011-0142806-0011-0542806-0011-10 |
| 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 |
Other NDCs under ANDA 072051
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 | A-S Medication Solutions | 50090-2093 |
| Sulindac | Sulindac 200 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-479 |