Oseltamivir
- Product NDC
- 42385-985
- 11-digit product format
- 423850985
- Labeler code
- 42385
- Product ID
- 42385-985_927cba3a-62cf-4e9f-9871-92835927ea46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oseltamivir phosphate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA218565
- Marketing category
- ANDA
- Marketing start
- 2024-05-02
- Substance
- OSELTAMIVIR PHOSPHATE
- Active strength
- 30 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OSELTAMIVIR PHOSPHATE | 30 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 |
|---|
| 42385-985-01 | Oseltamivir | 100 in 1 BOTTLE | CAPSULE | 100 | | 1 |
| 42385-985-10 | Oseltamivir | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 1 |
| 42385-985-11 | Oseltamivir | 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 |
|---|
| 42385-985 | OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) CAPSULE [LAURUS LABS LIMITED] | 1 | Current NDC, 3 package rows | 20240509_927cba3a-62cf-4e9f-9871-92835927ea46.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 |
|---|
| 42385-985-01 | 42385098501 | 100 CAPSULE in 1 BOTTLE (42385-985-01) | 100 capsule | 2024-05-02 | No | No | Current |
| 42385-985-10 | 42385098510 | 10 in 1 BLISTER PACK | | | | | Historical |
| 42385-985-11 | 42385098511 | 1 BLISTER PACK in 1 CARTON (42385-985-11) / 10 CAPSULE in 1 BLISTER PACK (42385-985-10) | 1 blister pack | 2024-05-02 | No | No | Current |