candesartan cilexetil and hydrochlorothiazide
- Product NDC
- 70771-1326
- 11-digit product format
- 707711326
- Labeler code
- 70771
- Product ID
- 70771-1326_2b38d778-d732-4a7b-bb34-b426a14e10bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- candesartan cilexetil and hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA203466
- Marketing category
- ANDA
- Marketing start
- 2018-04-14
- Substance
- CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
- Active strength
- 32; 12.5 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
- candesartan cilexetil and hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CANDESARTAN CILEXETIL | 32 mg/1 |
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, R85M2X0D68 |
| Rxcui | 578325, 578330, 802749 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1326-0 | candesartan cilexetil and hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 70771-1326-1 | candesartan cilexetil and hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 70771-1326-2 | candesartan cilexetil and hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET | 10 | | 5 |
| 70771-1326-3 | candesartan cilexetil and hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 70771-1326-4 | candesartan cilexetil and hydrochlorothiazide | 10 in 1 CARTON | TABLET | 10 | | 5 |
| 70771-1326-9 | candesartan cilexetil and hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1326 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [ZYDUS LIFESCIENCES LIMITED] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241113_cb328bc1-5738-4620-b2b3-442e98388a86.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1326-0 | 70771132600 | 1000 TABLET in 1 BOTTLE (70771-1326-0) | 1000 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 70771-1326-1 | 70771132601 | 100 TABLET in 1 BOTTLE (70771-1326-1) | 100 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 70771-1326-2 | 70771132602 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 70771-1326-3 | 70771132603 | 30 TABLET in 1 BOTTLE (70771-1326-3) | 30 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |
| 70771-1326-4 | 70771132604 | 10 BLISTER PACK in 1 CARTON (70771-1326-4) / 10 TABLET in 1 BLISTER PACK (70771-1326-2) | 10 blister pack | 2018-04-14 | 0000-00-00 | No | No | Current |
| 70771-1326-9 | 70771132609 | 90 TABLET in 1 BOTTLE (70771-1326-9) | 90 tablet | 2018-04-14 | 0000-00-00 | No | No | Current |