ORLISTAT
- Product NDC
- 61269-565
- 11-digit product format
- 612690565
- Labeler code
- 61269
- Product ID
- 61269-565_45add4e4-7806-4a6c-b360-e6e383d7e18e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- orlistat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- H2-Pharma LLC
- Application
- NDA020766
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-06-01
- 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
- ORLISTAT
- 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 | 314153 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-565-90 | ORLISTAT | 90 in 1 BOTTLE, PLASTIC | CAPSULE | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-565 | ORLISTAT CAPSULE [H2-PHARMA LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240709_f81dfaeb-46d5-47ce-9ef6-19259f5ac61c.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 |
|---|
| 61269-565-90 | 61269056590 | 90 CAPSULE in 1 BOTTLE, PLASTIC (61269-565-90) | 90 capsule | 2022-06-01 | 0000-00-00 | No | No | Current |