Valsartan and Hydrochlorothiazide
- Product NDC
- 62332-082
- 11-digit product format
- 623320082
- Labeler code
- 62332
- Product ID
- 62332-082_29d9e9d2-2c11-49c0-b397-cd429cf701df
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valsartan and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA201662
- Marketing category
- ANDA
- Marketing start
- 2016-05-20
- Substance
- HYDROCHLOROTHIAZIDE; VALSARTAN
- Active strength
- 12.5; 320 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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
- Valsartan and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| VALSARTAN | 320 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 80M03YXJ7I, 0J48LPH2TH |
| Rxcui | 200284, 200285, 349353, 636042, 636045 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62332-082-10 | Valsartan and Hydrochlorothiazide | 100 in 1 CARTON | TABLET, FILM COATED | 100 | 11 | |
| 62332-082-30 | Valsartan and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 11 | |
| 62332-082-71 | Valsartan and Hydrochlorothiazide | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 11 | |
| 62332-082-90 | Valsartan and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-082-71 | EA - Each | 62332-082 | fe9bf38a-6c25-439e-8c66-1fbef6c9afe5 | 1 | 2016-07-19 |
| 62332-082-90 | EA - Each | 62332-082 | 94079268-b631-4e3c-8248-9f5b206038f2 | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200284 | HCTZ 12.5 MG / valsartan 80 MG Oral Tablet | PSN | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 636042 | valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 636042 | hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet | SCD | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 200284 | hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet | SCD | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 636042 | HCTZ 12.5 MG / valsartan 320 MG Oral Tablet | SY | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 200284 | HCTZ 12.5 MG / valsartan 80 MG Oral Tablet | SY | 09c55798-5313-4250-8d8f-9c5644e8c1b0 | 21 |
| 200284 | HCTZ 12.5 MG / valsartan 80 MG Oral Tablet | PSN | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 200285 | valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 349353 | valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636042 | valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636045 | valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 200285 | hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet | SCD | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636042 | hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet | SCD | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 200284 | hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet | SCD | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 349353 | hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet | SCD | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636045 | hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet | SCD | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 200285 | HCTZ 12.5 MG / valsartan 160 MG Oral Tablet | SY | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636042 | HCTZ 12.5 MG / valsartan 320 MG Oral Tablet | SY | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 200284 | HCTZ 12.5 MG / valsartan 80 MG Oral Tablet | SY | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 349353 | HCTZ 25 MG / valsartan 160 MG Oral Tablet | SY | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636045 | HCTZ 25 MG / valsartan 320 MG Oral Tablet | SY | 973973a3-9fec-4afc-910f-187f099dfe2d | 11 |
| 636042 | valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | ec24af8d-29a3-4217-8f06-ac217ea55b9e | 3 |
| 636042 | hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet | SCD | ec24af8d-29a3-4217-8f06-ac217ea55b9e | 3 |
| 636042 | HCTZ 12.5 MG / valsartan 320 MG Oral Tablet | SY | ec24af8d-29a3-4217-8f06-ac217ea55b9e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 62332-082-10 | 62332008210 | 100 TABLET, FILM COATED in 1 CARTON (62332-082-10) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-082-30 | 62332008230 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-082-30) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-082-71 | 62332008271 | 500 TABLET, FILM COATED in 1 BOTTLE (62332-082-71) | 2016-05-20 | 0000-00-00 | No | No | Current |
| 62332-082-90 | 62332008290 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-082-90) | 2016-05-20 | 0000-00-00 | No | No | Current |