Amlodipine and Valsartan
- Product NDC
- 40032-080
- 11-digit product format
- 400320080
- Labeler code
- 40032
- Product ID
- 40032-080_fe621d98-188e-42fe-8ea6-3bc3467f9e49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine and Valsartan
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA202829
- Marketing category
- ANDA
- Marketing start
- 2015-03-30
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE; VALSARTAN
- Active strength
- 10 mg/1; mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 40032-080-03 | Amlodipine and Valsartan | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 40032-080-09 | Amlodipine and Valsartan | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| VALSARTAN | ACTIVE INGREDIENT | 80M03YXJ7I | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| VALSARTAN | ACTIVE MOIETY | 80M03YXJ7I | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40032-080 | AMLODIPINE AND VALSARTAN TABLET AMLODIPINE AND VALSARTAN TABLET [NOVEL LABORATORIES, INC.] | 5 | Legacy NDC, 2 package rows | 20150422_f4f7081c-a05c-436f-967b-34060087edda.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 40032-080-03 | 40032008003 | 30 in 1 BOTTLE | Historical |
| 40032-080-09 | 40032008009 | 90 in 1 BOTTLE | Historical |