Fosamprenavir Calcium
- Product NDC
- 63304-583
- 11-digit product format
- 633040583
- Labeler code
- 63304
- Product ID
- 63304-583_3397d9ea-26ac-a592-e063-6394a90ae937
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fosamprenavir Calcium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA204024
- Marketing category
- ANDA
- Marketing start
- 2019-11-28
- Substance
- FOSAMPRENAVIR CALCIUM
- Active strength
- 700 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fosamprenavir Calcium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSAMPRENAVIR CALCIUM | 700 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ID1GU2627N |
| Rxcui | 402109 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-583-01 | Fosamprenavir Calcium | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 10 |
| 63304-583-30 | Fosamprenavir Calcium | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 10 |
| 63304-583-60 | Fosamprenavir Calcium | 60 in 1 BOTTLE | TABLET, COATED | 60 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-583 | FOSAMPRENAVIR CALCIUM TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250427_5cd1eead-9fc1-426c-bee8-214ffa7d9dc1.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 |
|---|
| 63304-583-01 | 63304058301 | 100 TABLET, COATED in 1 BOTTLE (63304-583-01) | 2019-11-28 | 0000-00-00 | No | No | Current |
| 63304-583-30 | 63304058330 | 30 TABLET, COATED in 1 BOTTLE (63304-583-30) | 2019-11-28 | 0000-00-00 | No | No | Current |
| 63304-583-60 | 63304058360 | 60 TABLET, COATED in 1 BOTTLE (63304-583-60) | 2019-11-28 | 0000-00-00 | No | No | Current |