ORMALVI
- Product NDC
- 70709-085
- 11-digit product format
- 707090085
- Labeler code
- 70709
- Product ID
- 70709-085_8716de8d-f4b6-4192-892c-cb22b511257c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dichlorphenamide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cycle Pharmaceuticals Ltd.
- Application
- ANDA215924
- Marketing category
- ANDA
- Marketing start
- 2024-03-15
- Substance
- DICHLORPHENAMIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORMALVI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICHLORPHENAMIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VVJ6673MHY |
| Rxcui | 197594, 2677447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70709-085-10 | ORMALVI | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70709-085 | ORMALVI (DICHLORPHENAMIDE) TABLET [CYCLE PHARMACEUTICALS LTD.] | 1 | Current NDC, 1 package rows | 20240316_3989e220-6502-449b-be39-e2689acce08c.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 |
|---|
| 70709-085-10 | 70709008510 | 100 TABLET in 1 BOTTLE (70709-085-10) | 100 tablet | 2024-03-15 | No | No | Historical |