Hydrochlorothiazide
- Product NDC
- 0527-1413
- 11-digit product format
- 005271413
- Labeler code
- 0527
- Product ID
- 0527-1413_7ab02f2a-c630-488e-8395-cd83da05e565
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA084325
- Marketing category
- ANDA
- Marketing start
- 2007-05-01
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 0527-1413 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0527-1413 | 0527-1413-01 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0527-1413 | 0527-1413-10 | 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 |
|---|
| A084325-001 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | | Approved before 1982 | |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCHLOROTHIAZIDE TABLET [LANNETT COMPANY, INC.] | 7 | |
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCHLOROTHIAZIDE TABLET [ST MARYS MEDICAL PARK PHARMACY] | 5 | |
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCHLOROTHIAZIDE TABLET [APOTHECA, INC.] | 1 | |
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 |
|---|
| 0527-1413-01 | 00527141301 | 100 TABLET in 1 BOTTLE, PLASTIC (0527-1413-01) | 100 tablet | 2007-05-01 | 0000-00-00 | No | No | Current |
| 0527-1413-10 | 00527141310 | 1000 TABLET in 1 BOTTLE, PLASTIC (0527-1413-10) | 1000 tablet | 2007-05-01 | 0000-00-00 | No | No | Current |