OSELTAMIVIR PHOSPHATE
- Product NDC
- 76282-739
- 11-digit product format
- 762820739
- Labeler code
- 76282
- Product ID
- 76282-739_b9fa33ae-039e-4192-bda0-7797932d2653
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OSELTAMIVIR PHOSPHATE
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA212858
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- Substance
- OSELTAMIVIR PHOSPHATE
- Active strength
- 6 mg/mL
- 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 | 6 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4A3O49NGEZ |
| Rxcui | 1115698 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76282-739-52 | OSELTAMIVIR PHOSPHATE | 60 mL in 1 BOTTLE | FOR SUSPENSION | 60 | | 1 |
| 76282-739-52 | OSELTAMIVIR PHOSPHATE | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-739 | OSELTAMIVIR PHOSPHATE FOR SUSPENSION [EXELAN PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20231209_9fb09e82-42ef-4a2a-9bcd-3aab3ac52bb3.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 |
|---|
| 76282-739-52 | 76282073952 | 1 BOTTLE in 1 CARTON (76282-739-52) / 60 mL in 1 BOTTLE | 1 bottle | 2023-12-01 | No | No | Historical |