Sulindac
- Product NDC
- 0904-6217
- 11-digit product format
- 009046217
- Labeler code
- 0904
- Product ID
- 0904-6217_8f059053-2856-4abc-a23b-7e9bd780f637
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulindac
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA072711
- Marketing category
- ANDA
- Marketing start
- 2010-11-30
- Marketing end
- 0000-00-00
- Substance
- SULINDAC
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c7c8244c-3606-b814-8453-06ab13fc5907 | Product name | 2 | 20201015 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0904-6217-40 | 2024-02-22 | C162847 | 48780-1 | 1030e365-0c74-111a-e063-dadaa90a10e2 | 1a5125c7-a63e-4214-b179-668ecfcd16ac |
| 0904-6217-60 | 2024-02-22 | C162847 | 48780-1 | 1030e365-0c74-111a-e063-dadaa90a10e2 | 1a5125c7-a63e-4214-b179-668ecfcd16ac |
| 0904-6217-40 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0c74-111a-e063-dadaa90a10e2 | 1a5125c7-a63e-4214-b179-668ecfcd16ac |
| 0904-6217-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0c74-111a-e063-dadaa90a10e2 | 1a5125c7-a63e-4214-b179-668ecfcd16ac |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6217-40 | EA - Each | 0904-6217 | db426dd1-3223-4ce9-9fef-8e1690d0176d | 1 | 2013-02-13 |
| 0904-6217-60 | EA - Each | 0904-6217 | 17922bfe-3d32-428d-95a9-62b2777e1f39 | 1 | 2013-02-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198239 | sulindac 200 MG Oral Tablet | PSN | ddbbaada-f55a-4032-a24c-a8c493933a45 | 5 |
| 198239 | sulindac 200 MG Oral Tablet | SCD | ddbbaada-f55a-4032-a24c-a8c493933a45 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6217-40 | 00904621740 | 500 TABLET in 1 BOTTLE (0904-6217-40) | 500 tablet | 2010-11-30 | 0000-00-00 | No | No | Current |
| 0904-6217-60 | 00904621760 | 100 TABLET in 1 BOTTLE (0904-6217-60) | 100 tablet | 2010-11-30 | 0000-00-00 | No | No | Current |