Hydrochlorothiazide
- Product NDC
- 16729-182
- 11-digit product format
- 167290182
- Labeler code
- 16729
- Product ID
- 16729-182_4e6be915-b8a1-bef8-e063-6394a90a324c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA202556
- Marketing category
- ANDA
- Marketing start
- 2013-04-18
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
- Listing expiration
- 2027-12-31
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 |
|---|
| 16729-182-01 | Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 16729-182-17 | Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| Hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 1 | |
| Hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| Hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) TABLET [ACCORD HEALTHCARE INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-182 | HYDROCHLOROTHIAZIDE TABLET [ACCORD HEALTHCARE INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20200902_babb1b20-fe82-40ba-8e7a-0c56fe433b4a.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 |
|---|
| 16729-182-01 | 16729018201 | 100 TABLET in 1 BOTTLE (16729-182-01) | 100 tablet | 2013-04-18 | 0000-00-00 | No | No | Current |
| 16729-182-17 | 16729018217 | 1000 TABLET in 1 BOTTLE (16729-182-17) | 1000 tablet | 2013-04-26 | 0000-00-00 | No | No | Current |