Candesartan Cilexetil and Hydrochlorothiazide
- Product NDC
- 62559-660
- 11-digit product format
- 625590660
- Labeler code
- 62559
- Product ID
- 62559-660_f88f68dc-85bd-494d-b111-07701c619ea5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Candesartan Cilexetil and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA021093
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-09-26
- Substance
- CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
- Active strength
- 16; 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 | 16 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 |
|---|
| 62559-660-90 | Candesartan Cilexetil and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-660 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [ANI PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200513_bd8d318d-167a-4b26-935d-265dde3193de.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 |
|---|
| 62559-660-90 | 62559066090 | 90 TABLET in 1 BOTTLE (62559-660-90) | 90 tablet | 2018-09-26 | 0000-00-00 | No | No | Current |