Triamterene and Hydrochlorothiazide
- Product NDC
- 0781-2715
- 11-digit product format
- 007812715
- Labeler code
- 0781
- Product ID
- 0781-2715_ea03a6fb-76da-42f0-a855-81c50bec2240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamterene and Hydrochlorothiazide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA073191
- Marketing category
- ANDA
- Marketing start
- 1991-07-31
- Marketing end
- 2021-08-31
- Substance
- TRIAMTERENE; HYDROCHLOROTHIAZIDE
- Active strength
- 50 mg/1; mg/1
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0781-2715 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0781-2715 | 0781-2715-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0781-2715 | 0781-2715-10 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0781-2715 | 0781-2715-13 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A073191-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;50MG | CAPSULE / ORAL | | | 1991-07-31 |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| TRIAMTERENE | ACTIVE INGREDIENT | WS821Z52LQ | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| TRIAMTERENE | ACTIVE MOIETY | WS821Z52LQ | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| GLYCINE | INACTIVE INGREDIENT | TE7660XO1C | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-2715 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [SANDOZ INC] | 22 | Legacy NDC | 20240724_f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0.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 |
|---|
| 0781-2715-01 | 00781271501 | 100 CAPSULE in 1 BOTTLE (0781-2715-01) | 100 capsule | 1991-07-31 | 2021-08-31 | No | No | Current |