AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
- Product NDC
- 51407-668
- 11-digit product format
- 514070668
- Labeler code
- 51407
- Product ID
- 51407-668_369be7a6-2236-ab19-e063-6394a90a880f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate valsartan hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA201087
- Marketing category
- ANDA
- Marketing start
- 2015-06-01
- Substance
- AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 5; 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, HYDROCHLOROTHIAZIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 160 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 80M03YXJ7I, 864V2Q084H, 0J48LPH2TH |
| Rxcui | 848131, 848135, 848140, 848145, 848151 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51407-668-30 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51407-668-30 | EA - Each | 51407-668 | 683dc8ad-8d4e-46be-b0d7-d049d6fd2055 | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51407-668 | AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE (AMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240703_e9ecbadb-c548-6fe5-e053-2a95a90a7577.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 848131 | amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848151 | amLODIPine 10 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848135 | amLODIPine 10 MG / valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848140 | amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848145 | amLODIPine 5 MG / valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848131 | amlodipine 10 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet | SCD | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848151 | amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet | SCD | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848135 | amlodipine 10 MG / hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet | SCD | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848140 | amlodipine 5 MG / hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet | SCD | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848145 | amlodipine 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet | SCD | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848131 | amlodipine (as amlodipine besylate) 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848135 | amlodipine (as amlodipine besylate) 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848151 | amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848140 | amlodipine (as amlodipine besylate) 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848145 | amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848131 | amlodipine 10 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848151 | amlodipine 10 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848135 | amlodipine 10 MG / HCTZ 25 MG / valsartan 320 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848140 | amlodipine 5 MG / HCTZ 12.5 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
| 848145 | amlodipine 5 MG / HCTZ 25 MG / valsartan 160 MG Oral Tablet | SY | e9ecbadb-c548-6fe5-e053-2a95a90a7577 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51407-668-30 | 51407066830 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-668-30) | 2022-08-01 | 0000-00-00 | No | No | Current |