Hydrochlorothiazide
- Product NDC
- 29300-485
- 11-digit product format
- 293000485
- Labeler code
- 29300
- Product ID
- 29300-485_1e92de42-a7f2-4674-8260-28cfabf0759d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA040907
- Marketing category
- ANDA
- Marketing start
- 2025-04-03
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 12.5 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 | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH |
| Rxcui | 197770, 310798, 429503 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-485-01 | Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 29300-485-10 | Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| DIBASIC CALCIUM PHOSPHATE DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 5 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 29300-485-01 | 29300048501 | 100 TABLET in 1 BOTTLE (29300-485-01) | 100 tablet | 2025-06-12 | No | No | Current |
| 29300-485-10 | 29300048510 | 1000 TABLET in 1 BOTTLE (29300-485-10) | 1000 tablet | 2025-06-12 | No | No | Current |