Hydrochlorothiazide

Product NDC
76413-139
11-digit product format
764130139
Labeler code
76413
Product ID
76413-139_0996a36e-ed5e-4c05-a501-14f5f7ab2b98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Central Texas Community Health Centers
Application
ANDA040412
Marketing category
ANDA
Marketing start
2002-03-29
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
2019-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-139IInactivated by FDA2026-07-31
excluded packagepackage76413-13976413-139-30IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040412-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29
A040412-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions ). Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

warnings

Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a Whole Weakness. Cardiovascular Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal Muscle spasm. Nervous System/Psychiatric Vertigo, paresthesias, dizziness, headache, restlessness. Renal Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS ). Skin Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses Transient blurred vision, xanthopsia. Urogenital Impotence. Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-139-302020-01-31C16284748780-19d75b9d1-1fd7-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-139-30Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-139HYDROCHLOROTHIAZIDE TABLET [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 1 package rows20161207_f4267981-e62b-4767-b913-0019883c7eb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSNf4267981-e62b-4767-b913-0019883c7eb11
310798hydrochlorothiazide 25 MG Oral TabletSCDf4267981-e62b-4767-b913-0019883c7eb11
310798HCTZ 25 MG Oral TabletSYf4267981-e62b-4767-b913-0019883c7eb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-139-307641301393030 in 1 BOTTLE, PLASTICHistorical