NATEGLINIDE
- Product NDC
- 75834-205
- 11-digit product format
- 758340205
- Labeler code
- 75834
- Product ID
- 75834-205_4b5b12e1-59db-4ec2-a2be-9b60abc79ebf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- NATEGLINIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Nivagen Pharmaceuticals, Inc.
- Application
- ANDA206432
- Marketing category
- ANDA
- Marketing start
- 2019-09-25
- 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 |
|---|
| 75834-205-01 | NATEGLINIDE | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75834-205 | NATEGLINIDE TABLET, COATED [NIVAGEN PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20210116_21b211b5-cc92-490f-9903-42fff6a946cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 75834-205-01 | 75834020501 | 100 TABLET, COATED in 1 BOTTLE (75834-205-01) | 2019-09-25 | 0000-00-00 | No | No | Current |