Sulindac
- Product NDC
- 0591-5661
- 11-digit product format
- 005915661
- Labeler code
- 0591
- Product ID
- 0591-5661_988f11c7-805d-4926-84b3-4c9c0cb0038d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulindac
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA071891
- Marketing category
- ANDA
- Marketing start
- 1990-04-03
- 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 |
|---|
| 0591-5661-01 | Sulindac | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 13 |
| 0591-5661-05 | Sulindac | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SULINDAC | ACTIVE INGREDIENT | 184SNS8VUH | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SULINDAC | ACTIVE MOIETY | 184SNS8VUH | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| SULINDAC | ACTIVE INGREDIENT | 184SNS8VUH | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
| SULINDAC | ACTIVE MOIETY | 184SNS8VUH | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | SULINDAC TABLET [WATSON LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-5661 | SULINDAC TABLET [ACTAVIS PHARMA, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241210_d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4.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 |
|---|
| 0591-5661-00 | 00591566100 | 39000 TABLET in 1 BAG (0591-5661-00) | 39000 tablet | 03-APR-90 | | | | Current |
| 0591-5661-01 | 00591566101 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5661-01) | 100 tablet | 1990-04-03 | 0000-00-00 | No | No | Current |
| 0591-5661-05 | 00591566105 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-5661-05) | 500 tablet | 1990-04-03 | 0000-00-00 | No | No | Current |
| 0591-5661-77 | 00591566177 | 47064 TABLET in 1 CONTAINER (0591-5661-77) | 47064 tablet | 11-JUN-24 | | | | Current |