Tolectin
- Product NDC
- 50991-988
- 11-digit product format
- 509910988
- Labeler code
- 50991
- Product ID
- 50991-988_472dd96d-50bb-e82c-e063-6294a90af66d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tolmetin sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- ANDA074473
- Marketing category
- ANDA
- Marketing start
- 2024-04-04
- Substance
- TOLMETIN SODIUM
- Active strength
- 600 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
- Tolectin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TOLMETIN SODIUM | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 02N1TZF99F |
| Rxcui | 198297, 208048 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-988-30 | Tolectin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50991-988 | TOLECTIN (TOLMETIN SODIUM) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20240418_15467b19-e43a-5be9-e063-6294a90a3cca.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50991-988-30 | 50991098830 | 30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30) | 2024-04-04 | No | No | Current |