Sular
- Product NDC
- 70515-501
- 11-digit product format
- 705150501
- Labeler code
- 70515
- Product ID
- 70515-501_daa4568e-f725-4df3-85eb-ff0ede789c78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nisoldipine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Covis Pharma US, Inc
- Application
- NDA020356
- Marketing category
- NDA
- Marketing start
- 2017-02-03
- Substance
- NISOLDIPINE
- Active strength
- 17 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sular
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NISOLDIPINE | 17 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4I8HAB65SZ |
| Rxcui | 763519, 763521, 763589, 763591, 790489, 790840 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e04fa8b-4f0f-e220-dece-f7d74308b047 | Product name | 2 | 20200505 |
| 63cce84a-c151-e237-b0c1-b5e9928f1ca7 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70515-501-10 | Sular | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 6 | |
| 70515-501-10 | Sular | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70515-501-10 | EA - Each | 70515-501 | 2dc061a4-dbd0-4a9d-8430-7752b95bf146 | 1 | 2017-06-15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 763519 | nisoldipine 17 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763589 | nisoldipine 34 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790489 | nisoldipine 8.5 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763521 | Sular 17 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763591 | Sular 34 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790840 | Sular 8.5 MG 24HR Extended Release Oral Tablet | PSN | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763521 | 24 HR nisoldipine 17 MG Extended Release Oral Tablet [Sular] | SBD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763591 | 24 HR nisoldipine 34 MG Extended Release Oral Tablet [Sular] | SBD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790840 | 24 HR nisoldipine 8.5 MG Extended Release Oral Tablet [Sular] | SBD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763519 | 24 HR nisoldipine 17 MG Extended Release Oral Tablet | SCD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763589 | 24 HR nisoldipine 34 MG Extended Release Oral Tablet | SCD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790489 | 24 HR nisoldipine 8.5 MG Extended Release Oral Tablet | SCD | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763521 | 24 HR Sular 17 MG Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763591 | 24 HR Sular 34 MG Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790840 | 24 HR Sular 8.5 MG Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763519 | nisoldipine 17 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763589 | nisoldipine 34 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790489 | nisoldipine 8.5 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763521 | Sular 17 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 763591 | Sular 34 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
| 790840 | Sular 8.5 MG 24 HR Extended Release Oral Tablet | SY | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70515-501-10 | 70515050110 | 1 BOTTLE in 1 CARTON (70515-501-10) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2017-02-03 | 0000-00-00 | No | No | Current |