Amlodipine, Valsartan and Hydrochlorothiazide
- Product NDC
- 65862-835
- 11-digit product format
- 658620835
- Labeler code
- 65862
- Product ID
- 65862-835_a583a371-730c-4f0a-86b6-01e654770f16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine, Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206180
- Marketing category
- ANDA
- Marketing start
- 2017-12-19
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 5; 25; 160 mg/1; mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine, Valsartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H, 0J48LPH2TH, 80M03YXJ7I |
| Rxcui | 848131, 848135, 848140, 848145, 848151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-835-05 | Amlodipine, Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 8 |
| 65862-835-30 | Amlodipine, Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 65862-835-90 | Amlodipine, Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-835 | AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240521_6fba5243-ee00-4825-a04a-321cb6b49c56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-835-05 | 65862083505 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-835-05) | 2017-12-19 | 0000-00-00 | No | No | Current |
| 65862-835-30 | 65862083530 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-835-30) | 2017-12-19 | 0000-00-00 | No | No | Current |
| 65862-835-90 | 65862083590 | 90 TABLET, FILM COATED in 1 BOTTLE (65862-835-90) | 2017-12-19 | 0000-00-00 | No | No | Current |