Hydrochlorothiazide
- Product NDC
- 82804-973
- 11-digit product format
- 828040973
- Labeler code
- 82804
- Product ID
- 82804-973_4c1a2fb9-133d-4bd5-a336-e47d54f22c97
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA087068
- Marketing category
- ANDA
- Marketing start
- 2020-09-25
- 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
openFDA Listing Details
- Product ID
- 82804-973_4c1a2fb9-133d-4bd5-a336-e47d54f22c97
- SPL ID
- 4c1a2fb9-133d-4bd5-a336-e47d54f22c97
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
- Generic name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2020-09-25
- Marketing category
- ANDA
- Application number
- ANDA087068
- Pharmacologic classes
- Increased Diuresis [PE]; Thiazide Diuretic [EPC]; Thiazides [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0J48LPH2TH |
| Rxcui | 197770, 310798 |
| Spl Set Id | 4c1a2fb9-133d-4bd5-a336-e47d54f22c97 |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 82804-973-00 | 100 TABLET in 1 BOTTLE (82804-973-00) | 2025-02-13 | No |
| 82804-973-11 | 1000 TABLET in 1 BOTTLE (82804-973-11) | 2025-02-13 | No |
| 82804-973-30 | 30 TABLET in 1 BOTTLE (82804-973-30) | 2025-02-13 | No |
| 82804-973-55 | 500 TABLET in 1 BOTTLE (82804-973-55) | 2025-02-13 | No |
| 82804-973-60 | 60 TABLET in 1 BOTTLE (82804-973-60) | 2025-02-13 | No |
| 82804-973-72 | 120 TABLET in 1 BOTTLE (82804-973-72) | 2025-02-13 | No |
| 82804-973-90 | 90 TABLET in 1 BOTTLE (82804-973-90) | 2025-02-13 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0J48LPH2TH | HYDROCHLOROTHIAZIDE | 58-93-5 | HYDROCHLOROTHIAZIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-973-00 | 82804097300 | 100 TABLET in 1 BOTTLE (82804-973-00) | 100 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-11 | 82804097311 | 1000 TABLET in 1 BOTTLE (82804-973-11) | 1000 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-30 | 82804097330 | 30 TABLET in 1 BOTTLE (82804-973-30) | 30 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-55 | 82804097355 | 500 TABLET in 1 BOTTLE (82804-973-55) | 500 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-60 | 82804097360 | 60 TABLET in 1 BOTTLE (82804-973-60) | 60 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-72 | 82804097372 | 120 TABLET in 1 BOTTLE (82804-973-72) | 120 tablet | 2025-02-13 | No | No | Historical |
| 82804-973-90 | 82804097390 | 90 TABLET in 1 BOTTLE (82804-973-90) | 90 tablet | 2025-02-13 | No | No | Historical |