amlodipine,valsartan and hydrochlorothiazide
- Product NDC
- 33342-284
- 11-digit product format
- 333420284
- Labeler code
- 33342
- Product ID
- 33342-284_1ea4f227-b97a-49f1-bbc3-1dede2c1866d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine,valsartan and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA207299
- Marketing category
- ANDA
- Marketing start
- 2025-01-06
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 10; 12.5; 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 | 10 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 80M03YXJ7I, 864V2Q084H, 0J48LPH2TH |
| 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 |
|---|
| 33342-284-07 | amlodipine,valsartan and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 33342-284-10 | amlodipine,valsartan and hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
| 33342-284-12 | amlodipine,valsartan and hydrochlorothiazide | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 1 |
| 33342-284-12 | amlodipine,valsartan and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-284 | AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250112_1ea4f227-b97a-49f1-bbc3-1dede2c1866d.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 |
|---|
| 33342-284-07 | 33342028407 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-284-07) | | 2025-01-06 | No | No | Current |
| 33342-284-10 | 33342028410 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-284-10) | | 2025-01-06 | No | No | Current |
| 33342-284-12 | 33342028412 | 10 BLISTER PACK in 1 CARTON (33342-284-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2025-01-06 | No | No | Current |