ORLYNVAH
- Product NDC
- 81153-100
- 11-digit product format
- 811530100
- Labeler code
- 81153
- Product ID
- 81153-100_abcb22dd-7c10-4459-a98c-d03582b426a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sulopenem etzadroxil and probenecid
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ITERUM THERAPEUTICS US LIMITED
- Application
- NDA213972
- Marketing category
- NDA
- Marketing start
- 2025-07-01
- Substance
- PROBENECID; SULOPENEM ETZADROXIL
- Active strength
- 500; 500 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORLYNVAH
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROBENECID | 500 mg/1 |
| SULOPENEM ETZADROXIL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | PO572Z7917, 492M3I304T |
| Rxcui | 2717843, 2717850 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81153-100-01 | ORLYNVAH | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 81153-100-01 | ORLYNVAH | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81153-100-01 | 81153010001 | 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-07-01 | No | No | Current |