Xenical
- Product NDC
- 61269-460
- 11-digit product format
- 612690460
- Labeler code
- 61269
- Product ID
- 61269-460_4fd710c5-6147-498a-ade9-0cce6e1513c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- orlistat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H2-Pharma LLC
- Application
- NDA020766
- Marketing category
- NDA
- Marketing start
- 2010-12-17
- Substance
- ORLISTAT
- Active strength
- 120 mg/1
- Pharmacologic classes
- Intestinal Lipase Inhibitor [EPC], Lipase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xenical
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ORLISTAT | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 95M8R751W8 |
| Rxcui | 226917, 314153 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-460-90 | Xenical | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-460 | XENICAL (ORLISTAT) CAPSULE [H2-PHARMA LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240709_6240792b-9224-2d10-e053-2a91aa0a2c3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61269-460-90 | 61269046090 | 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-460-90) | 90 capsule | 2010-12-17 | 0000-00-00 | No | No | Current |