Oseltamivir Phosphate
- Product NDC
- 0527-4592
- 11-digit product format
- 005274592
- Labeler code
- 0527
- Product ID
- 0527-4592_00e310fb-2460-a1bf-e063-6394a90a2457
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- oseltamivir phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA212739
- Marketing category
- ANDA
- Marketing start
- 2023-05-15
- Substance
- OSELTAMIVIR PHOSPHATE
- Active strength
- 45 mg/1
- Pharmacologic classes
- Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oseltamivir Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OSELTAMIVIR PHOSPHATE | 45 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4A3O49NGEZ |
| Rxcui | 312122, 728109, 728113 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-4592-13 | Oseltamivir Phosphate | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
| 0527-4592-13 | Oseltamivir Phosphate | 1 in 1 CARTON | CAPSULE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-4592 | OSELTAMIVIR PHOSPHATE CAPSULE [LANNETT COMPANY, INC.] | 1 | Current NDC, 2 package rows | 20230720_00e2e995-6296-b544-e063-6294a90a8345.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0527-4592-13 | 00527459213 | 1 BLISTER PACK in 1 CARTON (0527-4592-13) / 10 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2023-05-15 | No | No | Current |