Nateglinide
- Product NDC
- 68382-721
- 11-digit product format
- 683820721
- Labeler code
- 68382
- Product ID
- 68382-721_061a2260-2804-4753-b443-17943eca74dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nateglinide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA205248
- Marketing category
- ANDA
- Marketing start
- 2016-10-27
- Substance
- NATEGLINIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Glinide [EPC], Potassium Channel Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nateglinide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NATEGLINIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 41X3PWK4O2 |
| Rxcui | 311919, 314142 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-721-01 | Nateglinide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
| 68382-721-05 | Nateglinide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 7 |
| 68382-721-06 | Nateglinide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
| 68382-721-10 | Nateglinide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 7 |
| 68382-721-16 | Nateglinide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 7 |
| 68382-721-77 | Nateglinide | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 7 |
| 68382-721-77 | Nateglinide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-721 | NATEGLINIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20231110_88698921-cd8f-4d41-96e6-ff671913c5c3.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 |
|---|
| 68382-721-01 | 68382072101 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01) | | 2016-10-27 | 0000-00-00 | No | No | Current |
| 68382-721-05 | 68382072105 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05) | | 2016-10-27 | 0000-00-00 | No | No | Current |
| 68382-721-06 | 68382072106 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-721-06) | | 2016-10-27 | 0000-00-00 | No | No | Current |
| 68382-721-10 | 68382072110 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-721-10) | | 2016-10-27 | 0000-00-00 | No | No | Current |
| 68382-721-16 | 68382072116 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-721-16) | | 2016-10-27 | 0000-00-00 | No | No | Current |
| 68382-721-77 | 68382072177 | 10 BLISTER PACK in 1 CARTON (68382-721-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2016-10-27 | 0000-00-00 | No | No | Current |