SULINDAC
- Product NDC
- 42806-018
- 11-digit product format
- 428060018
- Labeler code
- 42806
- Product ID
- 42806-018_fb793a0a-affa-4f9a-a5b4-aa1c84aa475e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SULINDAC
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA072710
- Marketing category
- ANDA
- Marketing start
- 2010-01-25
- Substance
- SULINDAC
- Active strength
- 150 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SULINDAC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SULINDAC | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 184SNS8VUH |
| Rxcui | 198238, 198239 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-018-01 | SULINDAC | 100 in 1 BOTTLE | TABLET | 100 | | 19 |
| 42806-018-05 | SULINDAC | 500 in 1 BOTTLE | TABLET | 500 | | 19 |
| 42806-018-10 | SULINDAC | 1000 in 1 BOTTLE | TABLET | 1000 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SULINDAC | ACTIVE INGREDIENT | 184SNS8VUH | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| SULINDAC | ACTIVE MOIETY | 184SNS8VUH | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SULINDAC TABLET [EPIC PHARMA, LLC] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-018 | SULINDAC TABLET [EPIC PHARMA, LLC] | 19 | Current NDC, Legacy NDC, 3 package rows | 20241222_96c73bd2-4577-487d-a642-bd8f91e94c3a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42806-018-01 | 42806001801 | 100 TABLET in 1 BOTTLE (42806-018-01) | 100 tablet | 2010-01-25 | 0000-00-00 | No | No | Current |
| 42806-018-05 | 42806001805 | 500 TABLET in 1 BOTTLE (42806-018-05) | 500 tablet | 2010-01-25 | 0000-00-00 | No | No | Current |
| 42806-018-10 | 42806001810 | 1000 TABLET in 1 BOTTLE (42806-018-10) | 1000 tablet | 2010-01-25 | 0000-00-00 | No | No | Current |