Hydrochlorothiazide
- Product NDC
- 43547-398
- 11-digit product format
- 435470398
- Labeler code
- 43547
- Product ID
- 43547-398_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA040412
- Marketing category
- ANDA
- Marketing start
- 2002-03-29
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- 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
- Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH |
| Rxcui | 197770, 310798 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-398-01 | Hydrochlorothiazide | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 2 |
| 43547-398-03 | Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
| 43547-398-05 | Hydrochlorothiazide | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | | 2 |
| 43547-398-10 | Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 2 |
| 43547-398-11 | Hydrochlorothiazide | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 2 |
| 43547-398-50 | Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-398 | HYDROCHLOROTHIAZIDE TABLET [SOLCO HEALTHCARE U.S., LLC] | 2 | Current NDC, Legacy NDC, 6 package rows | 20200915_60c97ab9-b25e-4ea5-a159-792292178c65.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 |
|---|
| 43547-398-01 | 43547039801 | 10 TABLET in 1 BOTTLE, PLASTIC (43547-398-01) | 10 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-03 | 43547039803 | 30 TABLET in 1 BOTTLE, PLASTIC (43547-398-03) | 30 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-05 | 43547039805 | 50 TABLET in 1 BOTTLE, PLASTIC (43547-398-05) | 50 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-10 | 43547039810 | 100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10) | 100 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-11 | 43547039811 | 1000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11) | 1000 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-50 | 43547039850 | 500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50) | 500 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |